Vaidlustus

11.06.2025 VAIDLUSTUS Riigihange: „Traumatoloogia metallosteosünteesi vahendid ja liigeste endoproteesid“ viitenumber: 295377 Vaidlustaja: OneMed OÜ registrikood: 10891247 aadress: Veerenni 38, 10138 Tallinn Esindaja: Erki Fels, vandeadvokaat Gregor Saluveer, vandeadvokaadi abi Advokaadibüroo TGS Baltic e-post: [email protected] Hankija: sihtasutus Tartu Ülikooli Kliinikum registrikood: 90001478 aadress: L. Puusepa 1a, Tartu 50406 e-post: [email protected] TAOTLUSED 1. Peatada riigihanke „Traumatoloogia metallosteosünteesi vahendid ja liigeste endoproteesid“ (vr 295377) menetlus kõikides riigihanke osades. 2. Kohustada sihtasutust Tartu Ülikooli Kliinikum viima õigusaktidega kooskõlla järgmised riigihanke alusdokumentide tingimused: 2.1. riigihanke osa 4 alusdokumendi „Lisa 4 osa 4 - Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega“ punkt 3; 2.2. riigihanke osa 4 alusdokumendi „Lisa 4 osa 4 - Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega“ punkt 4.1; 2.3. riigihanke osa 4 alusdokumendi „Lisa 4 osa 4 - Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega“ punkt 5.1; 2.4. riigihanke osa 4 alusdokumendi „Lisa 4 osa 4 - Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega“ punkt 6.1; 2.5 riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 6.1; 2.6. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 8.1; 2.7. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 8.2; 2.8. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 9.2; 2.9. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 9.3; 2.10. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 9.6; Advokaadibüroo TGS Baltic AS Ahtri 6a, 10151 Tallinn Kaluri 2, 51004 Tartu [email protected] Telefon +372 626 4300 Telefon +372 730 1610 2.11. riigihanke osa 10 alusdokumendi „Lisa 10 osa 10 - Mittetsemeneteeritav puusaprotees (põhiproteesina)“ punkt 1.5; 2.12. riigihanke osa 10 alusdokumendi „Lisa 10 osa 10 - Mittetsemeneteeritav puusaprotees (põhiproteesina)“ punkt 1.6; 2.13. riigihanke osa 10 alusdokumendi „Lisa 10 osa 10 - Mittetsemeneteeritav puusaprotees (põhiproteesina)“ punkt 2.5; 2.14. riigihanke osa 10 alusdokumendi „Lisa 10 osa 10 - Mittetsemeneteeritav puusaprotees (põhiproteesina)“ punkt 2.8; 2.15. riigihanke osa 10 alusdokumendi „Lisa 10 osa 10 - Mittetsemeneteeritav puusaprotees (põhiproteesina)“ punkt 3.1; 2.16. riigihanke osa 11 alusdokumendi „Lisa 11 osa 11 - Mittetsemeneteeritav puusaprotees (alternatiiv)“ punkt 1.1; 2.17. riigihanke osa 11 alusdokumendi „Lisa 11 osa 11 - Mittetsemeneteeritav puusaprotees (alternatiiv)“ punkt 1.2; 2.18. riigihanke osa 11 alusdokumendi „Lisa 11 osa 11 - Mittetsemeneteeritav puusaprotees (alternatiiv)“ punkt 1.6; 2.19. riigihanke osa 11 alusdokumendi „Lisa 11 osa 11 - Mittetsemeneteeritav puusaprotees (alternatiiv)“ punkt 1.7; 2.20. riigihanke osa 11 alusdokumendi „Lisa 11 osa 11 - Mittetsemeneteeritav puusaprotees (alternatiiv)“ punkt 2.4; 2.21. riigihanke osa 1 alusdokumendis „Lisa 1 osa 1 - tsemeneteeritav standardne puusaprotees (põhi)“ sätestatud nõuded, sealhulgas peatükk „Muud täiendavad komponendid“; 2.22. riigihanke osa 2 alusdokumendis „Lisa 2 osa 2 - tsemeneteeritav standardne puusaprotees (alternatiiv)“ sätestatud nõuded, sealhulgas peatükk „Muud täiendavad komponendid“; 2.23. riigihanke osa 3 alusdokumendis „Lisa 3 osa 3 - puusaliigese eriprotees“ sätestatud nõuded, sealhulgas peatükid „Muud täiendavad komponendid“ ja „Lisavahendid“; 2.24. riigihanke osa 5 alusdokumendis „Lisa 5 osa 5 - Tsemeneteeritav põlveprotees tagumise ristatisideme stabiliseerimisega“ sätestatud nõuded, sealhulgas peatükid „Lisavõimalused“ ja „Teised lisavõimalused“; 2.25. riigihanke osa 7 alusdokumendis „Lisa 7 osa 7 - Põlveliigese eriprotees“ sätestatud nõuded, sealhulgas punkt 8; 2.26. riigihanke osa 13 alusdokumendis „Lisa 13 osa 13 - Megaprotees“ sätestatud nõuded; 2.27. riigihanke alusdokumendi „Lisa_24_pakkumuse_maksumus“ punkt 2.3; 2.28. riigihanke osa 4 alusdokumendi „Lisa 4 osa 4 - Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega“ peatükid „Muud täiendavad komponendid“, „Lisavahendid“ ja „Teised lisavõimalused“; 2.29. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ peatükid „Lisavõimalused“, „Teised lisavõimalused“ ja „Muud täiendavad komponendid ja võimalused“; 2.30. riigihanke osa 7 alusdokumendi „Lisa 7 osa 7 - Põlveliigese eriprotees“ peatükid „Lisavõimalused“, „Teised lisavõimalused“ ja „Muud täiendavad komponendid ja võimalused“; 2.31. riigihanke osa 8 alusdokumendi „Lisa 8 osa 8 - Õlaliigese protees“ peatükk „Muud täiendavad komponendid ja võimalused“; 2/13  2.32. riigihanke osa 9 alusdokumendi „Lisa 9 osa 9 - Küünarliigese protees“ peatükk „Muud täiendavad komponendid ja võimalused“; 2.33. riigihanke osade 1—14 tehniliste kirjelduste tingimused, mis algavad sõnadega „Endoproteesi komplekti baashinna arvutamiseks /…/“; 2.34 riigihanke osade 1—23 tehniliste kirjelduste tingimused, mis algavad sõnadega „Pakkuja peab hankijale tagama spetsiifiliste instrumentide komplektid /…/“; 2.35. riigihanke osade 1—23 tehniliste kirjelduste tingimused, mis algavad sõnadega „Garanteeritud instrumentide komplektide arv arvestatakse /…/“ ja „Lisaks garanteeritud instrumentide komplektidele /…/“; 2.36. riigihanke alusdokumendi „Juhised pakkujale“ punktid 6.18—6.18.2 ja 7.2. 3. Jätta OneMed OÜ menetluskulud sihtasutuse Tartu Ülikooli Kliinikum kanda. 1. ASJAOLUD 1.1. 19.05.2025 avaldas sihtasutus Tartu Ülikooli Kliinikum (hankija) avatud hankemenetlusena läbiviidava riigihanke „Traumatoloogia metallosteosünteesi vahendid ja liigeste endoproteesid“ (vr 295377) (riigihange) hanketeate ja tegi kättesaadavaks riigihanke alusdokumendid (RHAD). Tehnilise kirjelduse (TK) järgi on hankelepingu esemeks traumatoloogia metallosteosünteesi vahendite ja liigeste endoproteeside ost. 1.2. Pakkumuste esitamise tähtpäev on 19.06.2025. 1.3. TK on vastuolus riigihangete seaduse (RHS) § 88 lg-ga 7 ja RHS § 3 p-dega 1—3 ja 5. Riigihanke osades 1, 2, 3, 4, 5, 6, 7, 10, 11 ja 13 on hankija koostanud TK nii, et neile vastab kindel toode. OneMed OÜ (vaidlustaja) osalemine riigihankes on põhjendamatult takistatud. Ülejäänud riigihanke osades on tingimused ebaselged, mistõttu pole vaidlustajal võimalik aru saada, kas tema pakutavad tooted tingimustele vastavad või mitte, või ebaproportsionaalsed. 1.4. Vaidlustaja taotleb riigihangete vaidlustuskomisjonilt (VAKO) kohustada hankijat viima TK õigusaktidega kooskõlla (RHS § 185 lg 2 p 1). 2. RIIGIHANKE PEATAMISE TAOTLUS 2.1. VAKO võib vaidlustaja põhjendatud taotluse alusel teha igas vaidlustusmenetluse staadiumis otsuse riigihanke peatamise kohta (RHS § 193 lg 1). Vaidlustaja taotleb riigihanke peatamist kõikides riigihanke osades, kuna kõikides osades on õigusvastaseid tingimusi, mis vaidlustaja õiguseid riivavad. Riigihanke peatamine on põhjendatud, kuna pakkumuste esitamise tähtpäev saabub enne VAKO otsuse tegemist (RHS § 200 lg 1).1 2.2. Vaidlustuse eesmärk on saavutada olukord, kus hankija kehtestaks õigusvastaste hanketingimuste asemel õiguspärased tingimused. Sellise eesmärgi saavutamine ei ole enam võimalik, kui pakkumused on esitatud. Kui pakkumuste esitamise tähtaeg möödub, on RHADis sätestatud tingimused kohustuslikud nii hankijale kui pakkujatele, kellel tuleb edasises menetluses nendest tingimustest lähtuda. VAKO ega kohus ei saa kohustada hankijat pärast pakkumuste esitamise tähtpäeva möödumist RHADi muutma.2 Vaidlustaja on valmis taotlusest loobuma, kui hankija soostub ise pakkumuste esitamise tähtpäeva edasi lükkama nii, et tagatud oleks VAKO otsuse tegemine ja ka kaebetähtaeg. 1 VAKO 93-18/194960, p 4. 2 TlnRKm 3-15-1817, p 10; VAKO 166-17/190812, p-d 8, 11—14; VAKO 187-17/192426, p-d 8, 11—14. 3/13 3. PÕHJENDUSED 3.1. Vaidlustaja vaidlustab tingimusi kahel põhjusel. Esiteks, TK on koostatud kindlate toodete järgi (ptk A). Teiseks, TK on ebaselge (ptk 3.6). A. TEHNILINE KIRJELDUS ON KOOSTATUD KINDLATE TOODETE JÄRGI 3.1. Hankija on koostanud TK-d vaidlustatud osades kindlate toodete spetsifikatsioonide järgi (täpsemalt toodud allolevas tabelis). TK-d tervikuna lugedes on selge, et hankija on lihtsalt kopeerinud TK-sse nende toodete omadused. 3.2. Riigihangete korraldamise üheks üldpõhimõtteks on konkurentsi efektiivne ärakasutamine (RHS § 3 p 3). Hankija on vaidlusaluse riigihanke kirjutanud n-ö lukku nendele pakkujatele, kes pakuvad neid tooteid, mille omadusi on TK-s kirjeldatud. TK ei tohi aga tekitada objektiivselt põhjendamatuid takistusi riigihangete avamisel konkurentsile (RHS § 88 lg 7). TK ei tohi olla koostatud nii, et tingimustele vastaks üksnes üks toode või pakkuja.3 3.3. Hanketingimused peavad olema põhjendatud. Praegune TK, millega suunatakse hankeleping kindlate toodete pakkujatele, kindlasti põhjendatud ei ole. Hankija ei tohi seada hankelepingu eset silmas pidades põhjendamatuid piiranguid, mis välistavad ausa ja läbipaistva konkurentsi või on mõistliku põhjenduseta piiravad. 4 Hanketingimus ei tohi minna kaugemale, kui riigihankes taotletava eesmärgi saavutamiseks on mõistlikult vajalik.5 3.4. Vaidlustaja juhib tähelepanu, et 2021. aastal korraldas hankija endoproteeside riigihanke (238201) sarnase ülesehitusega ja tulemuseks oli olukord, kus hankija maksis endoproteeside eest 4 aasta jooksul ebamõistlikult kõrget hinda võrreldes samade või paremate tulemustega Eestis kasutatavate endoproteesidega. Hankija tegevus ei vasta seega ka üldpõhimõttele kasutada rahalisi vahendeid säästlikult ja otstarbekalt (RHS § 3 p 5). 3.5. Allolevas tabelis on välja toodud tingimused, mis takistavad vaidlustajal pakkumust esitamast. Paremalt teises lahtris on viide dokumendile, millest nähtub, et hankija valitud tootel on olemas täpselt kehtestatud nõudele vastav omadus. Parempoolses lahtris selgitab vaidlustaja, miks ei ole nõuded sellised kujul põhjendatud. TK Viide hankija valitud Miks ei ole tingimus TK punkti sisu punkt tootele põhjendatud Osa 4: Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega Hankija nõuded kirjeldavad OÜ Wimberg poolt müüdava Waldemar Link tooteid „SymphoKnee“ ja „Gemini SL“ kombinatsioonis veel mõne Waldemar Linki tootega, mille edasimüügiõigus on vaid OÜ-l Wimberg. 3 „Reieluu ja sääreluu Dokument „SymphoKnee Nõue on objektiivselt komponentide väljavõte“ (lisa 1) põhjendamatu ja valitud kindla suuruse ühilduvus toote järgi. Kõigil tootjatel on vähemalt +/- 2 omad kombineeritavuse tabelid, suurust.“ mis täidavad samaväärselt hankija eesmärki. 3 TlnRnKo 3-10-3225, p 18. 4 TlnHKo 3-20-582, p 12. 5 VAKO 34-19/206183, p 15. 4/13  4.1 “mobiilse ja Dokument „Gemini SL Nõue on objektiivselt toestatud kande surgical technique“ (lisa põhjendamatu ja valitud kindla komponendid;” 2), lk 2 toote järgi. Mobiilne kanne võib käia roteeruva tibia platoo mõistena, mitte reieosa komponendi nõudena. 5.1 “mobiiline kanne ja Dokument „Gemini SL Nõue on objektiivselt fikseeritud kanne;” surgical technique“ (lisa põhjendamatu ja valitud kindla 2), lk 2 toote järgi. Mobiilse kande nõude eesmärk on füsioloogiline liigese rotatsioon, eri tootjad lahendavad seda erinevalt süsteemipõhiselt, näiteks mediaalselt roteeruv protees. See täidab samaväärselt hankija eesmärki. 6.1 „Ülikõrge Dokument „Link Nõue on objektiivselt molekulmassiga Symphoknee Surgical põhjendamatu ja valitud kindla polüetüleenist technique“ (lisa 3), lk 65 toote järgi. Laialtlevinud standard (UHMWPE) on HXLPE või tootjaspetsiifiline liugpinnad.“ variant, mis täidab samaväärselt või paremini hankija eesmärki. UHMWPE materjal antud nõude kombineerimisel ülejäänud nõuetega on konkurentsi välistav. Osa 6: Erikonstruktsiooniga tsemeneteeritav põlveprotees Hankija nõuded kirjeldavad OÜ Ortolink Invest poolt müüdavat Smith & Nephew toodet „Primary Knee System“. 6.1 „reisosa materjal Dokument „OXINIUM- “Keramiseeritud metall” on üks keramiseeritud Knee-Brochure“ (lisa 4), võimalustest lahendada metall (ZrNb), et lk 4 probleemi, mis esineb 1-l sobiks ka patsiendil 100st (metalliallergia). metalliallergiaga Tegemist on Smith & Nephew patsientidele“ patenteeritud tehnoloogiaga (OXINIUM). On olemas ka alternatiive, nt Ti-Nidium, mis täidavad samaväärselt hankija eesmärki. 8.1 “plastikosa igal Dokument „Legion TKS „High flex insert“ on nimetus, mida mõõdul vähemalt 9 surgical technique“ (lisa kasutab ainult Smith & Nephew erinevat kõrgust, 5), lk 46 oma plastikosade kirjeldamiseks. high flex ja Teised tootjad võivad selle constrained tingimuse eesmärki täita näiteks variandid;” erilise disainiga reie komponendiga. 5/13 8.2 “vähemalt 6 Dokument „Legion TKS Nõue on objektiivselt erinevat surgical technique“ (lisa põhjendamatu ja valitud kindla polüetüleenist 5), lk-d 59 ja 61 toote järgi. Enamik süsteeme liigestuva pinna algab suurusest 10mm, mis suurust, CCK täidab samaväärselt hankija versioonil eesmärki. paksusega alates 9 mm;” 9.2 „Monteeritavad Dokument „Legion TKS Nõue objektiivselt põhjendamatu intramedullaarsed surgical technique“ (lisa ja valitud kindla toote järgi. Igal pikendused: varre 5), lk 59 tootjal on oma suuruste ja pikendused alates pikkustega varred, mis vastavad diameetrist 10 mm, süsteemile ja täidavad pikkusega vähemalt samaväärselt hankija eesmärki. vahemikus 80 mm – 275 mm, sirged. Tsemendivabad ja tsemendiga versioonid.“ 9.3 “Revisjonvarred: Dokument „Legion TKS Nõue on objektiivselt pikendused koos surgical technique“ (lisa põhjendamatu ja valitud kindla mõõdetava Offset- 5), lk 59 toote järgi. Igal tootjal on oma ga , alates suuruste ja pikkustega varred, mis diameetrist 9 mm ja vastavad süsteemile ja täidavad pikkusega vähemalt samaväärselt hankija eesmärki. vahemikus 120 – 270 mm. Nii tsementeeritavad kui tsemendivabad.” 9.6 „Põlvekedra Dokument „Legion TKS Nõue on objektiivselt protees: vähemalt surgical technique“ (lisa põhjendamatu ja valitud kindla kolme erineva 5), lk 48 toote järgi. Igal tootjal on oma kujuga ja vähemalt suuruste ja variatsioonidega 6 erineva põlvekedra proteesid, mis paksusega.“ vastavad süsteemile ja täidavad samaväärselt hankija eesmärki. Osa 10: Mittetsemeneteeritav puusaprotees (põhiproteesina) Hankija nõuded kirjeldavad OÜ Ortolink Invest poolt müüdavaid Smith & Nephew tooteid „SL Plus MIA“ ja „R3“ kombinatsioonis veel mõne Smith & Nephew tootega, mille edasimüügiõigus on vaid OÜ-l Ortolink Invest. 1.5 “reieosa 2 erineva Dokument „SL PLUS Nõue on objektiivselt kaela nurgaga- MIA Surgical technique“ põhjendamatu ja valitud kindla standard (131°) ja (lisa 6), lk 16 toote järgi (täpselt 131°). Vaidlustaja toote puhul on reieosa 6/13  lateraliseeritud 2 erineva kaela nurgaga: standard (123°);” (133°) ja lateraliseeritud (123°). See täidab hankija eesmärki samaväärselt. 1.6 ”reieosa kaela Dokument „SL PLUS Nõue on objektiivselt pikkus standard MIA Surgical technique“ põhjendamatu ja valitud kindla varrel 17-49mm ja (lisa 6), lk 17 toote järgi (täpselt 17-49mm ja lateraliseeritud 26-58mm). Vaidlustaja toote puhul variandil 26-58mm” on reieosa kaela pikkus standard varrel 28,3-49,4mm ja lateraliseeritud variandil 33,6- 54,6mm. See täidab hankija eesmärki samaväärselt. 2.5 ”napa sisemine - Nõue on objektiivselt vooder saadaval nii põhjendamatu. PE vooder on PE kui XLPE vananenud tehnoloogia. Kuna PE variandis;” voodriga implantaatide kliinilised tulemused on kehvemad kui näiteks XLPE versioonil, siis ei paku enamik vastutustundlikuid tootjad enam PE versiooni. Kuna hankija nõuab nii üht kui teist, teeb hankija võimatuks XLPE variandis tooteid pakkuda (mis ei täida hankija eesmärki isegi samaväärselt, vaid paremini). 2.8 „Pressfit napaosa Dokument „R3 Surgical Nõue on objektiivselt suurused 40mm – technique“ (lisa 7) lk-d 13 põhjendamatu ja valitud kindla 80 mm millele ja 17. toote järgi. 0° ja 10° sobivad XLPE kõrgendusega on saavutatav plastikosad 0° ja samaväärne tulemus, mis 0° ja 20° kõrgendusega;“ 20° kõrgendusega. 3.1 „reiepea materjal Dokument „OXINIUM- „Keramiseeritud metall” on Smith keramiseeritud Knee-Brochure“ (lisa 4), & Nephew patenteeritud metall (ZrNb);“ lk 4 tehnoloogia (OXINIUM). On olemas ka alternatiive, nt Ti- Nidium, mis täidavad samaväärselt hankija eesmärki. Osa 11: Mittetsemeneteeritav puusaprotees (alternatiiv) Hankija nõuded kirjeldavad OÜ Wimberg poolt müüdavat Waldemar Link toodet „SP- CL“ kombinatsioonis veel mõne Waldemar Link tootega, mille edasimüügiõigus on vaid OÜ-l Wimberg. 7/13  1.1 ”bioloogiliselt/anato Dokument „SP-CL Nõue on objektiivselt omiliselt sobilik, Product Rationale“ (lisa põhjendamatu. S-kõverus on mille S-kõverus 8), lk 3 ainult Waldemar Linki toodetele järgib reieluu omane omadus. Samaväärseid loomulikku või paremaid kliinilisi tulemusi on anatoomilist kuju;” võimalik saavutada ka teiste kujudega proteesidega. 1.2 ”Vasaku ja parema Dokument „SP-CL Vasak ja parem versioon on poole versioonid” Anatomically Adapted vajalikud anatoomilise disaini Cementless Hip System“ puhul. Samaväärsete või (lisa 9), lk 3 paremate tulemustega teise disainiga vartel ei ole vaja vasakut ja paremat versiooni. 1.6 ”Kahe CCD nurga Dokument „SP-CL Nõue on objektiivselt võimalus – 126 ja Anatomically Adapted põhjendamatu ja valitud kindla 135 kraadi” Cementless Hip System“ toote järgi (täpselt 126 ja 135 (lisa 9), lk 3 kraadi, nagu Waldemar Link tootel). 1.7 ”Reieosal vähemalt Dokument „SP-CL Vasak ja parem versioon on 18 erinevat suurust Anatomically Adapted vajalikud anatoomilise disaini vasakule ja Cementless Hip System“ puhul. Samaväärsete või paremale” (lisa 9), lk 3 paremate tulemustega teise disainiga vartel ei ole vaja vasakut ja paremat versiooni. 2.4 ”napaosa võimalik - Nõue on objektiivselt modulaarsete põhjendamatu ja valitud kindla komponentidega toote järgi. 0° ja 10° 10° ja 20° serva kõrgendusega on saavutatav kõrgendada” samaväärne tulemus, mis 0° ja 20° kõrgendusega. 3.6. Lisaks eelnevale vaidlustab vaidlustaja TK-sid tervikuna osades 1, 2, 3, 5, 7 ja 13. Riigikohus on selgitanud, et tingimuste kogum on õigusvastane, kui selle eesmärk on ebakohastel eesmärkidel konkreetse ettevõtja soosimine.6 Viidatud osade TK-d on kogumis koostatud nii, et neile vastavad vaid ühe tootja tooted: a. Osa 1 („tsementeeritav standardne puusaprotees (põhiproteesina)“) nõuded kirjeldavad OÜ Wimberg poolt müüdavat Waldemar Link toodet „Lubinus SPII“ kombinatsioonis veel mõne Waldemar Link tootega, mille edasimüügiõigus on vaid OÜ-l Wimberg. b. Osa 2 („tsementeeritav standardne puusaprotees (alternatiivse proteesina)“) nõuded kirjeldavad OÜ Ortolink Invest poolt müüdavaid Smith & Nephew tooteid „Polar Stem“ ja „Polar Cup“ kombinatsioonis veel mõne Smith & Nephew tootega, mille edasimüügiõigus on vaid OÜ-l Ortolink Invest. c. Osa 3 („puusaliigese eriprotees“) nõuded kirjeldavad OÜ Wimberg poolt müüdavat Waldemar Link toodet „Link MP Reconstruction“ kombinatsioonis veel mõne Waldemar 6 RKHKo 3-20-718, p 18. 8/13  Link tootega, mille edasimüügiõigus on vaid OÜ-l Wimberg. d. Osa 5 („tsemeneteeritav põlveprotees tagumise ristatisideme stabiliseerimisega“) nõuded kirjeldavad Johnson&Johnson AB Eesti filiaali poolt müüdava DePuy Synthese toodet „Attune“. e. Osa 7 („põlveliigese eriprotees“) nõuded kirjeldavad OÜ Wimberg poolt müüdava Waldemar Link põlveproteesi kombinatsioonis veel mõne Waldemar Link tootega, mille edasimüügiõigus on vaid OÜ-l Wimberg. f. Osa 13 („megaprotees“) nõuded kirjeldavad OÜ Wimberg poolt müüdava Waldemar Link tooteid. Eriti ilmselt avaldub see tõsiasi TK punktis 5, kus nõuab hankija, et pakutav toode peab olema kombineeritav põlveliigese Endo-model põlve implantaadi ning puusaliigese MP rekonstruktsiooni proteesiga. Tegemist on Waldemar Link toodetega. Lisaks, Eestis on erinevatel tootjatel oluliselt kaasaegsemaid lahendusi, mille kliinilised tulemused on paremad kui mainitud Endo-model proteesil. B. TEHNILINE KIRJELDUS ON EBASELGE 3.7. Teatud TK tingimusi vaidlustab vaidlustaja ka põhjusel, et nende sisu on ebaselge ning seega vastuolus läbipaistvuse põhimõttega (RHS § 3 p 1). Vaidlustajal ei ole nende tingimuste sisu ebaselguse tõttu võimalik aru saada, kas tema pakutavad tooted tingimustele vastavad või mitte. 3.8. Vaidlustaja hinnangul on hankija teadlikult koostanud segaste ning asjatundmatute mõistetega, tihti omavahel vastuolevad tingimused, et varjata soovi osta kindlaid tooteid kindlatelt edasimüüjatelt. TK punkt TK punkti sisu Miks on tingimus ebaselge Osa 7 TK punkt „Peab ühilduma Pakkujal pole võimalik aru saada, millega 8 megaproteesi (osa 13) peab osas 7 hangitav põlveliigese komponentidega.“ eriprotees ühilduma. See, millist toodet hankija osa 13 („megaprotees“) raames hangib, sõltub sellest, milline pakkumus osutub edukaks. Pakkumuse esitamise hetkel ei ole olemas „megaproteesi (osa 13) komponente“, millega oleks üldse ühilduda võimalik. Jääb mulje, nagu hakkab hankija osas 7 kontrollima pakkumuste vastavust selle alusel, milline pakkumus osutus edukaks osas 13. Selline teguviis on ilmselgelt õigusvastane. Lisa 24 Esitada tuleb „reiepea Osas 2, millega pakkumuse maksumuse (pakkumuse komplekti“ hind. vormi (lisa 24) punkt 2.3 korreleerub, ei maksumuse ole sellist asja nagu „reiepea komplekt“. tabel), punkt 2.3 Tsemendilise puusaproteesi varre külge ei paigaldata komplekte, vaid reiepäid. Terminist “reiepea komplekt” võib aru saada kui mitmest osast koosnevast lahendusest, mis on oluliselt kallim tavapärasest reiepeast. Hankija on teabevahetuses kinnitanud, et tegemist 9/13  on „inimliku eksimusega“ ja ta peab silmas reiepead, kuid ei ole hankedokumente parandanud. Hankijal ei ole võimalik teabevahetuse teel hankedokumente muuta. Maksumuse vormi ebaselgus võib põhjustada pakkumuste tagasi lükkamise või maksumuste võrreldamatuse. Osade 1—4 ja TK-des on osad nõuded Ebaselgeks jääb, mida need nõuded 10 TK-de liigitatud kui „Muud endast kujutavad – kas tegemist on peatükid „Muud täiendavad komponendid“, kohustusliku nõuetega või mitte. täiendavad „Lisavahendid“, „Teised Dokumendi „Juhised pakkujale“ p-s 1.4 komponendid“ lisavõimalused“, on kirjutatud, et mistahes dokumendis „Lisavõimalused“, „Muud sätestatud kohustus, tingimus või nõue Osade 3–4 TK- täiendavad komponendid ja on pakkujale kohustuslik. Sama de peatükid võimalused“. dokumendi p-s 6.9 on kirjas, et „Lisavahendid“ pakutavad tooted peavad vastama Osade 4—7 TK- kõikidele TK-s esitatud nõuetele. See on de peatükid ka loogiline, kuna tehniline kirjeldus on „Teised „asjade omaduste ja neile esitatavate lisavõimalused“ nõuete loetelu“ (RHS § 87 lg 1 p 1). Osade 5—7 TK- Teabevahetuses (ID 972062) on hankija de peatükid aga andnud teada, et n-ö lisanõuete „Lisavõimalused“ täitmine pole siiski kohustuslik: „Need ei ole kohustuslikud, kuid kui pakkujal on Osade 6—9 TK- neid pakkuda, peavad need olema de peatükid sobivad ja ühilduvad nõutud „Muud implantaatidega.“ Hankija ei saa täiendavad teabevahetuse kaudu muuta komponendid ja kohustuslikku tingimust vabatahtlikuks võimalused“ (RHS § 46 lg 3). Hankija ei ole lubanud alternatiivsete pakkumuste esitamist („Juhised pakkujale“ p 3.4). Ka praktilises mõttes jääb täiesti arusaamatuks, kuidas saavad olla teatud TK nõuded iseloomuga „kui pakkujal on pakkuda, siis paku“. Hankija peab hanketingimusi muutma, et sellest tuleneks üheselt selgelt, kuidas pakkujad peavad n-ö lisanõuete osas käituma. Ebaselgus võib põhjustada pakkumuste tagasi lükkamise või maksumuste võrreldamatuse. Seejuures on ilmselgelt asjakohatu hankija põhjendus, justkui võimaldavad lisavõimalused „saada pakkumusi laiemalt“, arvestades et hankija on TK-d kirjutanud lukku kindlatele toodetele. Osade 1—14 „Endoproteesi komplekti Jääb arusaamatuks, miks on vaja TK-de baashinna arvutamiseks endoproteesi komplekti baashinda. Mitte tingimused, mis liidetakse kõige enam kusagil mujal hanketingimustes ei ole 10/13  algavad kasutatavate mõõtudega reie, viidet endoproteesi komplekti sõnadega sääre ja liigespinna baashinnale. Millise metoodika järgi „Endoproteesi komponentide hinnad.“ liidetake kõige enam kasutatavate komplekti mõõtudega reie, napa ja reiepea baashinna komponentide hinnad ja miks seda vaja arvutamiseks on? Kust tuleb sisend „enim kasutatavate /…/“ mõõtude jaoks“? Pole aru saada, millele pakkuja selles tingimuses kinnituse annab. Osade 1—23 Jääb arusaamatuks, mida tähendab TK-de instrumentide komplekti “tagamine”. „Pakkuja peab hankijale tingimused, mis Endoproteeside valdkonnas on tagama spetsiifiliste algavad tavapärane, et hanke võitja annab instrumentide komplektid, sõnadega instrumentide komplekti(d) tasuta mille maksumus on arvutatud „Pakkuja peab kasutamiseks. Kui tegemist on väga vähe implantaatide osana (nn hankijale kasutatavate implantaatidega, siis on ka garanteeritud instrumentide tagama võimalus, et hankija ostab instrumentide komplektid).“ spetsiifiliste komplekti välja. Sõnakasutus „tagama“ instrumentide põhjustab ebaselgust, millele pakkuja komplektid /…/“. oma kinnituse andma peab. „Tagama“ viitab sellele, et pakkujal peab olema teoreetiline võimekus komplekte hankijale tarnida, mitte ei pea ta neid kindlasti tarnima. Osade 1—23 „Garanteeritud instrumentide Jääb arusaamatuks, mida tähendab TK-de komplektide arv arvestatakse “garanteeritud instrumentide komplekt”. tingimused, mis 1 komplekt/100 endoproteesi Mujal hanketingimused eristata algavad täiskomplekti kohta.“ „garanteeritud“ ja „garanteerimata“ sõnadega komplekte. Valdkonnas väljakujunenud „Lisaks garanteeritud „Garanteeritud tava on, et instrumendid kas antakse instrumentide komplektidele instrumentide tasuta kasutamiseks või hankija ostab on hankijal õigus instrumente komplektide arv instrumendid välja või kasutatakse või komplekte ka täiendavalt arvestatakse laenuinstrumente (instrumendid tuuakse osta pakkumuses märgitud /…/“ ja „Lisaks kohale, kui hankija selleks soovi hindadega.“ garanteeritud avaldab). Pole aru saada, kes, kellele ja instrumentide mida garanteerib. komplektidele Samuti on arusaamatu hankija nõue /…/“. saada endale 1 komplekt garanteeritud instrumente 100 endoproteesi täiskomplekti kohta. Kui pakkuja kinnitab selle tingimusega nõustumust, peab ta olema valmis tarnima hankeperioodi jooksul kuni 20 komplekti instrumente ühe osa kohta. Tavapäraselt saab hankija hakkama 1—3 instrumentide komplektiga ühe hanke osa kohta kogu hankeperioodi jooksul (3—4 aastat). Kuna tegemist on sedavõrd tavatu (ja ebaselge) nõudega, 11/13  ei ole aru saada, millele pakkuja peab kinnituse andma. Täiendavat segadust tekitab punkt, millega hankija annab endale õiguse lisaks garanteeritud instrumentide komplektidele instrumente või komplekte ka täiendavalt osta pakkumuses märgitud hindadega. Mis mahus, mis tingimustel ja mis alusel hankija lisatellimusi esitama hakkab? Kuna juba mõiste „garanteeritud instrumentide komplektid“ on ebaselge, pole aru saada, millele pakkuja peab kinnituse andma. Instrumentide vajadus ja nende tarnimise tingimused peavad olema selged. C. TEHNILINE KIRJELDUS ON EBAPROPORTSIONAALNE 3.9. Viimaks vaidlustab vaidlustaja dokumendi „Juhised pakkujale“ punkte 6.18—6.18.2 ja 7.2: Punkt 6.18: „Hankijal on õigus nõuda pakkuja poolt pakutud toodete näidiseid koos paigaldamiseks vajalike instrumentidega nende toodete vastavuse tuvastamiseks (sh hankijale eesmärgipäraseks kasutamiseks sobivuse määramiseks) läbi funktsionaalsete omaduste praktilise testimise. Näidis peab olema originaalpakendis, varustatud toote koodi/ref.nr-ga, toote nimetusega ja vastava pakkumuse osa numbriga.“ Punkt 6.18.1: „Näidis tuleb viia L. Puusepa 8, Tartu, ortopeediakliiniku ortopeedia osakonda (ruum H 156) või saata postiga samale aadressile. Tellimuse täitmise tähtaeg on 7 (implantaadi näidis) või 14 (implantaadi näidis koos paigalduseks vajalike instrumentidega) kalendripäeva alates tellimuse esitamisest. Tellimuse mittetähtaegsel täitmisel tunnistatakse pakkumus mittevastavaks.“ Punkt 6.18.2. „Tootenäidiste maksumust ei hüvitata pakkujale. Näidise paigalduseks vajalikud instrumendid tagastatakse pakkujale pärast hankemenetluse lõppemist, testimise tarbeks kasutamise eest ei tasuta.“ Punkt 7.2: „Toodete vastavuse tuvastamiseks võib hankija vajadusel moodustada ekspertkomisjoni, kes hindab näidiste vastavust praktilise testimise teel. Toodete praktiline testimine protokollitakse. Kui toote praktilise testimise käigus ilmneb, et toode ei vasta kirjeldatud omadustele või kasutustehnoloogiale või esineb tehnilisi tõrkeid toote kasutamisel või toode ei täida ootuspäraselt eesmärki või omab varjatud puudusi, on hankijal õigus tunnistada pakkumus mittevastavaks.“ 3.10. Esiteks, tingimused on ebaproportsionaalsed (RHS § 3 p 1). Need nõuded annavad hankijale nt õiguse nõuda kõikide komponentide kõikide suuruste kohaletoomist. Primaarproteeside puhul tähendab selline nõue pakkujale orienteeruvalt 30—100 tuhande euro suurust kulutust. Revisioon- või megaproteesi puhul võivad summad ulatuda sadade tuhandeteni. Sealjuures peavad pakkujad suutma hankija nõude täita 7 või 14 kalendripäevaga. Olukorras, kus hankijal on võimalik toodete vastavust kontrollida tehnilise dokumentatsiooni alusel – vajaduse korral nõudes välja ka täiendavaid tõendeid –, on pakkumuste vastavuse kontrollimine sellisel viisil pakkujad ilmselgelt ebamõistlikult koormav. 3.11. Teiseks, tingimused on läbipaistmatud (RHS § 3 p 1). Ebaselgeks jääb, kelle käest asub pakkuja näidiste toomist nõudma. Vastavust tuleb kontrollida kõikide pakkumuste puhul (RHS § 114 lg 1). Tingimuste sõnastusest tulenevalt on hankijal aga õigus nõuda näidiste toomist vaid ühe pakkuja puhul, kusjuures nõude täitmata jätmine on eraldiseisev mittevastavuse alus ja sellega kaasnevat kulu pakkujale ei hüvitata. On ilmselgelt õigusvastane olukord, milles hankija kontrollib 12/13  pakkumuste vastavust erineval moel. Lisaks, kui pakkuja ei pea näidiste toomisega kaasnevat kulu äriliselt mõistlikuks (ja hankija teab seda), on hankijal sisuliselt võimalik tõrjuda hankemenetlusest pakkuja, kes talle ei sobi. Pingereas teise pakkuja puhul pole aga hankija kohustatud näidiste toomist nõudma, kuna tegemist on tema õigusega. 4. MENETLUSLIKUD KÜSIMUSED 4.1. Riigilõiv. Vaidlustaja on tasunud vaidlustuse eest riigilõivu 1280 eurot (RLS § 258 lg 1 p 2) (lisa 10). 4.2. Esindus. Vandeadvokaat Erki Fels ja vandeadvokaadi abi Gregor Saluveer kinnitavad, et on vaidlustaja lepingulised esindajad (RHS § 190 lg 11). 4.3. Tähtaegsus. Pakkumuste esitamise tähtpäev on 19.06.2025. Vaidlustus on tähtaegne (RHS § 189 lg 2 p 2). 4.4. Läbivaatamine. Vaidlustaja on nõus kirjaliku menetlusega (RHS § 190 lg 1 p 6). 4.5. Esitamine. Vaidlustus on esitatud VAKO-le e-posti teel ([email protected]). Lugupidamisega (digitaalselt allkirjastatud) Erki Fels, Gregor Saluveer, vandeadvokaat vandeadvokaadi abi LISAD Lisa 1 SymphoKnee väljavõte Lisa 2 Gemini SL Surgical technique Lisa 3 Link SymphoKnee Surgical technique Lisa 4 OXINIUM-Knee-Brochure Lisa 5 Legion TKS Surgical technique Lisa 6 SL PLUS MIA surgical technique Lisa 7 R3 Surgical technique Lisa 8 SP-CL Product Rationale Lisa 9 SP-CL Anatomically Adapted Cementless Hip System Lisa 10 Riigilõivu tasumist tõendav maksekorraldus 13/13  GEMINI SL Total Knee System Surgical Technique Explanation of Pictograms Manufacturer Article number Product meets the applicable requirements, which are regulated in Material (number) the EU harmonization legislation for the affixing of the CE marking. Contents GEMINI SL Total Knee System 02 System Description GEMINI SL 03 Indications / Contraindications Surgical Technique Implantate 04 Overview – Workflow of Surgical Steps Femoral Components (cemented/cementless) 06 Preoperative Planning 54 Fixed Bearing CR/Mobile Bearing 07 Approaches to be used with PE Articulating Surfaces Fixed Bearing CR and Mobile Bearing Femoral Preparation – Distal Resection 55 PS (Posterior Stabilzed) – to be used with Fixed 08 Predetermining the Femoral Size Bearing PS PE Articulating Surfaces 09 Femoral Intramedullary Alignment 56 Fixed Bearing – to be used with Fixed Bearing CR 10 Distal Femoral Resection and PE Articulating Surfaces PS 12 SIT-CUT Instruments - Tibia Plateau Resection 57 Mobile Bearing – to be used with Mobile Bearing 16 Set Tibial Resection Level PE Articulating Surfaces 17 Tibial Sizing Tibial Components (cemented/cementless) 18 Checking Extension Gap and Axes 58 Articular Surface Fixed Bearing CR Final Femoral Preparation to be used with Femoral Components CR (Cruciate 19 Femoral Sizing Retaining) and Fixed Bearing Tibial Components 19 Rotation Setting 60 Articular Surface Fixed Bearing PS to be used with Femoral Components PS and Fixed 21 A/P Femoral Resection and Chamfer Cuts Bearing Tibial Components 22 Fixed Bearing PS (Posterior Stabilized) 62 Articular Surface Mobile Bearing Tibial Preparation to be used with Femoral Components CR (Cruciate 23 Tibial Sizing Retaining) and Mobile Bearing Tibial Components 24 Tibial Stem Preparation 64 Taper Caps for Tibial Components and Patella Resurfacing Components Patella Preparation (Patella Resurfacing) 65 Tibial Stems: cemented and cementless 25 Patella Sizing 26 Resection Instruments 27 Reaming 66 GEMINI SL Instrument Set – Overview 30 Trial Reduction and Functional Test 67 Case 1: SIT-CUT Easy Tibia Resection Alignment 68 Case 2: Femoral Preparation Implantation 69 Case 3: Spacer 32 Compatibility Table 70 Case 4: Tibia Preparation 33 Tibia Implant Overview 71 Case 5: Femoral Trial Prostheses 34 Implantation: Mobile Bearing 72 Case 6: Femoral PS Preparation 36 Implantation: Fixed Bearing and Fixed Bearing PS 73 Case 7: General Instruments 37 Patella Implantation 74 Case 8: Final-Spacer 38 Functional Test 75 Patella Instrument Set 39 APPENDIX 1: Precision Tibial Resection 76 Precision Tibia Resection Alignment Alignment - Extramedullary Alignment 77 EXTRABONE Instrument Set 44 APPENDIX 2: Precision Tibial Resection Alignment – Intramedullary Alignment 78 Additional Instruments: Adapter, Sawblades 49 APPENDIX 3: GEMINI SL EXTRABONE 79 Accessories: X-ray Templates – Extramedullary Femoral Referencing 80 Further Information Important Information 01  System Description The GEMINI SL Knee Surface Replacement allows native joint reconstruction with extensive range of motion and good kinematics.1, 2, 3 • The extended Femoral Shield and the deep Patellar Groove can lead to a physiological patellar motion and patellar self-guidance.1 • The antomical adapted Tibial Component allows for a better cortical coverage and thereby to an improved homogeneous force loading.4 • The Tibial Component is securely anchored by means of blades, pegs and stem, imporoving resistance against shear, rotation and tilting force.5 • The systems consists of Fixed Bearing Cruciate Retaining (CR), Fixed Bearing Posterior Stabilized (PS) and Mobile Bearing versions and there are optional tibial stems available which expand the range of indications and enable a comprehensive treatment option. • The options shown are additionally available with the LINK PorEx Technology*. PorEx is a TiNbN = Titanium-Niobium-Nitride surface modification that significantly reduces the release of chromium and nickel ions. It is a ceramic-like surface that is very hard improving wetting angle and results in a low coefficient of friction.6 • All versions can be selected cemented and cementless. Cruciate Retaining Posterior Stabilized Mobile Bearing (MB) Fixed Bearing (CR FB) Fixed Bearing (PS FB) Cruciate Retaining configuration for Posterior Stabilized configuration for Rotating highly congruent artricular use with intact ligaments and cap- use with absence of posterior cruciate surface for use with or without poste- sule and adequate joint stability. ligament. Reduces the risk of disloca- rior cruciate ligament.7 Identical tibial metal gtray for Fixed tion and decreases contact pressure Bearing CR and PS. in deep flexion.8 Featuring bone pre- serving design with size specific inter- condylar femoral box dimensions. * LINK PorEx: TiNbN = Titanium Niobium Nitride; hypoallergenic coating (gold color). 1 H. Thabe, „Auswirkungen verschiedener konstruktiver Prothesenmerkmale auf Langzeitergebnisse“, Akt Rheumatol 2013;38 2 Interne Daten – H. Thabe, „Aspekte zum Konzept der beweglichen Tibiaplateaukonstruktion, April 2000 3 J. Goodfellow, „The Mechanics of the Knee and Prosthesis Design”. J Bone Joint Surg Br 1978; 60:358-36 4 Figgie, H.E. et al.: Load-bearing Capacity of the Tibial Component of the Total Condylar Knee Prosthesis; Clin Orth & Rel Res, No. 183, 1984 5 Walker P.S., Hu-Ping Hsu, Zimmermann R.A.: „A comparative study of uncemented tibial components“ J of Arthrop, Vol. 5, No. 3, 1990, pp. 246-253 6 Internal Data oin file: Study of the influence of TiNbN-coating in the ion release of CoCRMO-alloys in SBF buffer simulator testing 7 Internal data on file: Innocenti B. White Paper GEMINI SL Mobile BEaring CR: Biomechnical Analysis in healthy and deficient PCL patient, 2017 8 Internal data on file: Innocenti B., White Paper GEMINI SL Fixed BEaring PS: Biomechnical Analysis of the Post-Cam System, 2017 02 Indications/Contraindications Specified indications and contraindications: GEMINI SL Total Knee Replacement GEMINI SL Cruciate Retaining Fixed Bearing (CR FB) Indications: Any form of uni-, bi- or tricompartimental arthritis of the knee joint (e.g. primary degenerative arthritis, secon- dary arthritis resulting from rheumatoid arthritis, fracture, post-infection, gout, chondrocalcinosis and others) Contraindications (absolute): Acute and chronic infections, local and systemic, insofar as they may compromise the successful implantation Moderate or severe instability or complete loss of the medial or collateral ligament Instability or loss of the posterior cruciate ligament Any bone defect that will result in insufficient implant fixation (based on the fact, that using stems, bone grafts and metal bone substitutes like cones, a minimum bone stock for implant fixation cannot be defined) Severe insufficiency or loss of extensor mechanism Contraindications (relative): Extension deficit >30° Varus or valgus deformity >30° Allergy to one of the implant materials GEMINI SL Posterior Stabilized Fixed Bearing (PS FB) Indications: Any form of uni-, bi- or tricompartimental arthritis of the knee joint (e.g. primary degenerative arthritis, secon- dary arthritis resulting from rheumatoid arthritis, fracture, post-infection, gout, chondrocalcinosis and others) Contraindications (absolute): Acute and chronic infections, local and systemic, insofar as they may compromise the successful implantation Moderate or severe instability or complete loss of the medial or collateral ligament Any bone defect that will result in insufficient implant fixation (based on the fact, that using stems, bone grafts and metal bone substitutes like cones, a minimum bone stock for implant fixation cannot be defined) Severe insufficiency or loss of extensor mechanism Contraindications (relative): Allergy to one of the implant materials GEMINI SL Mobile Bearing (MB) Indications: Any form of uni-, bi- or tricompartimental arthritis of the knee joint (e.g. primary degenerative arthritis, secon- dary arthritis resulting from rheumatoid arthritis, fracture, post-infection, gout, chondrocalcinosis and others) Contraindications (absolute): Acute and chronic infections, local and systemic, insofar as they may compromise the successful implantation Moderate or severe instability or complete loss of the medial or collateral ligament Any bone defect that will result in insufficient implant fixation (based on the fact, that using stems, bone grafts and metal bone substitutes like cones, a minimum bone stock for implant fixation cannot be defined) Severe insufficiency or loss of extensor mechanism Contraindications (relative): Allergy to one of the implant materials Implants with TiNbN-Coating In contrast to all other implants an allergy against one of the implant materials is not a contraindication. Otherwise the above mentioned indications and contraindications depending on the design of the TiNbN-coated implants remain the same. 03  Overview – Workflow of Surgical Steps Extension Gap First Tibial Resection SIT-CUT Preoperative Distal Femoral Resection Planning (Approach) Tibial Resection “Precision Tibia“ Tibia First Tibial Resection SIT-CUT Preoperative Distal Femoral Resection Planning (Approach) Tibial Resection Checking Extension “Precision Tibia“ Gap and Axes Femur First a/p Femoral Resection Tibial Preparation and Chamfer Cuts SIT-CUT optional alternative Preoperative Distal Femoral Resection Planning (Approach) Preparation PS Tibial Preparation (Posterior Stabilized) “Precision Tibia“ 04 Overview – Workflow of Surgical Steps The GEMINI SL Instruments are designed to meet the need of today’s knee surgeons. The instrumentation assures precise and reliable bone resections and allow a variety of surgical options. 1 Preparation maybe initiated at either the femur or the tibia. Spacer blocks are provided for extension and flexion gap evaluation. Patella instrumentation is available for compatible preparation of patella resurfacing. Furthermore, it is available a dedicated instrumentation to perform an extramedullary femoral referencing. a/p Femoral Resection alternative and Chamfer Cuts Preparation PS (Posterior Stabilized) Tibia Sizing Trial Reduction and Implantation Functional Test 1 Internal data on file 05  Surgical Technique Preoperative Planning The anatomic landmarks in the knee joint are defined preoperatively by imaging the whole leg on the healthy and the affected side in the standing position. The angle between the anatomic axis (center of knee joint – intramedullary canal) and the mechanical axis (center of femoral head – center of knee joint – center of ankle to the second toe) determines the valgus angle (01). These angles should be determined for both knees. The valgus angle of a healthy knee joint is 5°–7°. In comparison with the healthy side, and for the purpose of reconstructing the corresponding valgus angle in the affected knee joint, this angle must be determined before carrying out the distal femoral resection. The appropriate implant size can be selected preoperatively with X-ray templates. The necessary resections are determined by the size of the implant. 01 01 06 Surgical Technique Approaches With the knee in slight flexion, a straight incision is made over the patella, as far as the tibial tuberosity (02). A medial parapatellar incision is made through the patellar retinaculum, capsule and synovial membrane (03). When making the parapatellar incision, the patella is pushed to one side to visualize the femoro-patellar joint. Removal of the hypertrophic synovial membrane and parts of the fat pad allow access to the medial, lateral and intra­condylar parts of the joint. Excess synovia should be removed in order to avoid postoperative impingement and adhesions. Some surgeons prefer total synovectomy. 02 03 Alternative Approaches: Midvastus Subvastus Widely used approach, performed with Special approach for a smaller incision a simple and shorter incision 07  Surgical Technique Femoral Preparation – Distal Femoral Resection Predetermining the Femoral Size The GEMINI SL Femoral Component permits size-specific distal resection: Sizes 1-2B distal femoral cutting block "S" Sizes 3-5 distal femoral cutting block "L" The femoral sizer (04) is used to verify the femoral size determined in preoperative planning and to select the distal femoral cutting block. The femoral size is determined by holding the femoral sizer against the bone – the contour shown corresponds to size 3 (04-a). If the femur profile is smaller, the distal cutting block "S" should be selected. If the femur profile is a perfect fit or larger, the distal cutting block "L" should be used. The m/l dimension can be checked in addition (04-b). Size > = L m/l 04 m/l 04-a 04-b 08 Surgical Technique Femoral Intramedullary Alignment For femoral preparation, the knee is flexed to 90°. The entry point for opening the femur can be marked with the electrocautery (05). It is usually located approx. 3-5 mm medially above the intercondylar fossa. The medullary canal is opened with the step drill (06). 05 05 06 Connect the T-handle to the IM guide rod and insert the guide rod carefully. Remove the T-handle (07). 07 According to the previously selected femoral size ("S" or "L"), the distal cutting block is connected to the alignment instrument for valgus angle. Then, the preoperatively determined valgus angle is set, and the instrument is attached to the intramedullary guide rod (08-a, 08-b). 08-a 08-b 09  Surgical Technique Before fixing the distal cutting block with two drill pins, it must be ensured that at least one condyle is in contact with the alignment instrument, and that the valgus angle of the correct side has been set. The two drill pins are inserted through the holes labeled "0" (09). Then the alignment instrument for valgus angle is separated from the distal cutting block and removed. The intramedullary guide rod is then removed (10). 09 10 Distal Femoral Resection The cutting template can be used to check the alignment of the distal resection (11). 11 To ensure that the instrument is stable, a third drill pin is inserted into oblique hole. There is the option of inserting a fourth drill pin (12). 12 10 Surgical Technique The distal saw cut (sawblade 1.27 mm) is made at 90° flexion. Then the cutting block is removed (13). 13 The parallel drill pins remain in position (14). Note: It is possible to set the extension gap by means of post-resection. 14 11  Surgical Technique SIT-CUT Instruments – Tibia Plateau Resection Extramedullary Alignment For external alignment of the tibial resection instrument set, the extramedullary guide is assembled and adjusted to suit the length of the tibia. Note: For intramedullary alignment the precision tibial alignment instrument set is used. The application is described in Appendix II. Components The extramedullary guide consists of E following components: 15.5 EM Alignment Rod (15.1) F proximal with drill pin fixation EM Alignment Guide (15.2) - foot clamp silicone belt fixation (15.3-a) - foot clamp spring fixation (15.3-b) D 15.4 C 15.1 A: Locking screw foot clamp posterior slope B: Locking screw varus/valgus C: Locking screw EM alignment rod 15.2 Symmetrical Tibial Cutting Block (15.4) 15.4-L (alternatively: asymmetrical left/right versions 15.4- L/R) D D: Locking screw Stylus (E) with guide (F) (15.5) The stylus comes in different versions with the following designations: 15.4-R B D 12 for GEMINI SL Mobile Bearing 10 for GEMINI SL Fixed CR and Fixed PS 2 for GEMINI SL Defect Referencing A Alignment is carried out in reference to the anterior edge of the tibia. When the alignment rod is parallel to the tibia, the resection is at 90°, which means 0° 15.3-a posterior slope. Note: The tibial cutting block has no integrated slope. 15.3-b 12 Surgical Technique Assembly The requisite components are assembled as follows: Release locking screws (C) and (D). Push the EM alignment rod (15.1) through the tibial cutting block (15.4-L) and into the EM alignment guide (15.2). Hand-tighten the locking screws (C) and (D).). Release locking screw (A). Insert the foot clamp (15.3-a or 15.3-b) into the align- ment guide with the flat surface facing upward, and hand- tighten the screw (A). Release the locking screw at the stylus guide, then insert the foot guide (15.5) with stylus into the tibial cutting block (15.4). 15.1 Hand-tighten the locking screw. 15.5 15.4-L D C 15.2 15.3-a A 15.3-b 13  Surgical Technique Positioning Note: Fixation of the ankle is achieved either by the silicone belt or the optional spring clamp. Attach the foot clamp to the ankle joint and secure with the silicone belt (16). 16 Release the locking screw (C). Place the EM alignment rod considering varus/valgus and rotation (17). The axis of the EM alignment rod should be positioned with reference to the tibial axis. Proximal fix the EM alignment rod using a drill pin. Depending on the anatomical structure the drill pin either can be positioned into the tibial plateau or alter- natively into anterior tibial cortex. Note: After inserting the drill pin there is still the possibility to set rotational position, varus/valgus orientation and posterior slope. Tighten the locking screw (C). C 17 14 Surgical Technique Alignment Rotation (18) To determine the correct alignment of the rotation, the alignment instrument is aligned centrally along the tibial shaft axis. Varus-valgus (18) To set the varus/valgus, release the screw (B) and carry out this adjustment by shifting the alignment guide medially/laterally. Then tighten the screw (B) again. 5° B 7.2 18 C Posterior Slope (19) GEMINI SL – Tibia Slope Recommendations: For Mobile Bearing and a Fixed Bearing Cruciate Retaining (CR) configuration it is recommended to set the tibial posterior slope at 5 degrees. For a Fixed Bearing Posterior Stabilized (PS) configuration, a range of 0–5 degrees of tibial posterior slope is recommended. After releasing the distal setting screw (A), the alignment instrument can be til- ted by shifting the alignment rod axially, which in turn allows the requested posterior slope to be set. Once the correct position is reached, the setting B screw on the EM alignment guide (A) is tightened. Finally finish by firmly tightening all screws (A,B,C). A 19 15  Surgical Technique Set Tibial Resection Level Use the tibial stylus (E) to set the resection height. E Select and position the stylus: 12 for GEMINI SL Mobile Bearing 10 for GEMINI SL Fixed and Fixed PS 2 for GEMINI SL Defect Referencing The stylus “10” respectively “12“ is positioned on the highest point of the best- preserved area of the tibial plateau (20). Stylus “2” is choosen to align according the defect. D Release the locking screw (D) allowing to move the tibial cutting block until the stylus rests on the tibial plateau.Then hand-tighten the locking screw (D). 20 Afterwards secure the tibial cutting block with two drill pins through the anterior parallel holes with the "0" marking. Remove the tibial stylus. The cutting template can be used to check the alignment of the tibial resection (20-a). Any necessary corrections to the position (by ± 2 mm) can be carried out at this point. Fix the cutting block medially with a third drill pin (20-b) and then perform the resection (20-c). 20-a 20-b 20-c 16 Surgical Technique Tibial Sizing Following the resection, the third drill pin and the tibial saw guide are removed. The anterior drill pins remain in position (21). 21 The tibial implant size can now be determined by applying the appropriate tibial sizer. The instrument must cover the cortical bone optimally, without projecting beyond it (22). The tibial implant size can also serve as an indicator for the femoral implant size if the femoral measurement is between two sizes. 22 17  Surgical Technique Checking Extension Gap and Axes After careful cleaning of the soft tissues, the extension spacer “S” or “L” is inserted, according to previously used distal femur cutting block, and both the axial alignment and the stability of the joint in extension are checked (23-a, 23-b). 23-a 23-b If no further resections are required, the femoral and tibial drill pins can now be removed. 18 Surgical Technique Final Femoral Preparation Femoral Sizing For final femoral preparation, the next step is to determine the definitive femoral size. The femur sizer is applied to the distal femoral resection surface. Attention: The femoral sizer is anterior refernce only. Note: Please ensure that the femur sizer sits flush on the distal resection. The femur sizer can be applied over the intra-medullary guide rod to ensure stable positioning. 24 Place the femoral stylus anterior on the femur with the tip referencing the desired exit point of the sawblade for the anterior cut. This is usually half way up lateral, anterior prominence of the femoral trochlea. This measurement determines the adaptation of the femoral implant size to the A/P dimension. To check the M/L dimension of the selected size, the appropriate femur trial can be held against it. The femoral size is read off from the right side (24). Two drill pins are used to fix the size and, at the same time, to fix the frame of the measuring instrument to the distal resection 25 surface (25). Rotation Setting The alignment instrument allows external rotation in reference to the posterior condyle tangent, whiteside line or epicondylar line (26). The external rotation can be adjusted by turning the rotation setting screw until the alignment references are matched (27). Whiteside line: Alignment rod in the window to match the whiteside line Epicondylar line: Collateral pegs align with the epicondylar line Rotation setting Posterior condyle tangent: Readable degree indicate external rotation screw setting aligned to posterior condyle tangent Alignment rod for whiteside line Whiteside line Scale for femoral rotation setting – reference to posterior condyle Epicondylar line tangent 26 nt ndyle tange Posterior co 27 Alignment of epicondylar axis 19  Surgical Technique Optional: Checking Flexion Gap The flexion gap can be checked before finally defining the rotation setting and the femoral resection. Flex the knee joint 90°. The stepped end of the spacer for the selected size (28) is now slid under the control block so that the higher end rests against the control block (29-a, 29-b). The stepped design means that the condyles are exposed. 28 29-a 29-b Once the correct rotation has been set, the instrument is fixed with two drill pins through the medial and lateral holes (30). These drill pins are the guide reference for the position of the femoral cutting block. 30 The alignment instrument is removed, but the two drill pins remain in situ (31). 31 20 Surgical Technique A/P Femoral Resection and Chamfer Cuts The femoral cutting block is attached over the drill pins (32-a). Optional: The flexion gap can be checked or corrected by using the correction spacer in combination with femoral cutting block (32-b).The spacer is with his stepped side pushed as far as under the block, until it rests on the highest point under the femoral cutting block. The flexion gap can be adjusted by reallocating the femoral cutting block prior to the final resection. The femoral cutting block is fixed with drill pins with stop (Ø 3.5 mm). Optional it is possible to use the threaded pins (Ø 3.5 mm) with stop for the fixation of the femoral cutting lock (32-c). 32-a 32-b 32-c Note: The cutting template (angle wing) can be used to check the alignment of the individual resections, especially the anterior cut ensuring that notching is unlikely to occur. The anterior cut is carried out first, followed by the posterior, then the anterior and posterior chamfer cuts (33). 33 After that, the trochlea is prepared with the rasp (34-a, 34-b). 34-a 34-b 21  Surgical Technique Fixed Bearing PS (Fixed Bearing Posterior Stabilized) The box guide is selected according to the size of the femur and is positioned on the resected end of the femur. Alignment is performed according to the notch and the m/l dimension (35). Note: The box guide is symmetrically designed to permit universal use. Marking guide lines enable orientation and alignment (36). 35 Exterior contour for Exterior contour for aligning on the lateral, aligningon the lateral, right femoral condyle left femoral condyle Marking guide line Marking guide line mL (medial left) mR (medial right) Left implant Right implant 36 The box guide is fixed with at least two drill pins, or with three if preferred (37). The notch reamer is used to prepare the box: 1 Drill in Position 1 (38.1+2) 2 Drill in Position 2 (38.3) 37 3 Smooth the resection by passing the notch trephine from Position 1 to Position 2 38.1 38.2 38.3 Femur bone after completion of resection (39). 39 22 Surgical Technique Tibial Preparation Tibial Sizing The tibial implant size can now be determined by applying the appropriate tibial preparation plate. Select the tibial size to achieve maximal tibial coverage (40). After applying the appropriate tibial sizer and aligning the rotation with the aid of the extramedullary alignment rod (41), the tibial preparation plate is fixed. Two head pins are inserted centrally into the tibial plate (42-a, 42-b). 40 Option: Additional two head pins can be inserted anterior. 42-a 42-b 41 23  Surgical Technique Tibial Stem Preparation The blade chisel is used to prepare the two guides and the anchoring holes for the drill pins for the tibia base plate (43-a, 43-b). 43-a 43-b Then the guide sleeve is inserted (44) and the taper guide is reamed (45-a, 45-b). Note: The choice of reamer depends on which treatment option is selected: tibial taper cap or stem extension. 44 45-a 45-b To avoid impingement in flexion, remove any excess bone between the posterior tibial implant and the posterior femoral condyles in flexion. Use a curved osteotome or gouge to remove any remaining bone and osteophytes (46). 46 24 Surgical Technique Patella Preparation (Patella Resurfacing) The following operating instructions describe the use of the LINK Patella Component and assume the use of the instrument set available for this procedure. Both the “reaming of the patella surface” technique and the “resection of the patella surface” technique are shown. Using the calliper allows the height of the patella to be determined (47). The dimension is established and an amount corresponding to the size of the selected implant subtracted. The remainder equals the target dimension following resection. A minimal residual dimension of 12 mm should be maintained. Example: For a patella size 2 (patella diameter 28 mm), the following calculation is performed: 1. patella 25 mm thick, 2. resection 8 mm, 3. 17mm re-maining patella bone (47). 47 Patella Size Patella-Ø Patella Height 1 25 mm 7 mm 2 28 mm 8 mm 3 31 mm 9 mm 4 34 mm 10 mm Preparation for Patella Component The patella surface can be prepared using the onlay technique by resecting with an oscillating saw or with the aid of the parella reamer. Resection The height of the bone to be resected can be adjusted b using the height calliper (a) on the resection clamp (48). a 48 In doing this, it is important to ensure that the b remaining patella is sufficiently thick. The patella is held using the toothed jaws. The sectional plane must lie parallel to the extended patellar tendon and the height calliper must lie on the bone. In order to clamp the patella firmly, the clamp is compressed firmly and fixed using the lateral setting screw (b) (49). 49 25  Surgical Technique The resection is carried out using an oscillating saw with a 1.27 mm thick sawblade. The saw is guided using the saw slots of the resection clamp (50). 50 Sizing A patella sizing template corresponding to the implants is available (51.1) The template is selected that most adequately covers the articular surface without any overhang. The handle is positioned on the medial side of the everted patella. If bone is deficient on the lateral side, the next smaller size is selected, but positioned slightly to the medial side to enhance patellar tracking (51.2). 51.1 51.2 Option: Onlay Reaming c Reaming Preparation The reaming guide (c) of the appropriate size is inserted into the patella clamp (d) (52). Note: Press the button on the side to insert and remove the guide. d 52 26 Surgical Technique A ratchet can be activated on the clamp with the retaining screw (e). By turning the screw to “ON” the e clamp is held shut. By turning the screw to “OFF”, the ratchet is released (53). 53 Following removal of the peripheral osteophytes, the patella is clamped with the patella holding clamp, aiming at the most central position possible (54). Good fixation is achieved when the spikes on the guide grip into the bone. 54 Reaming The patella reamer is selected (f) to match the im- plant size which was previously determined and the f corresponding reaming guide (55).The patella reamer has a Hudson drill connection for direct fixation with corresponding power tool connection. It is compatible with other machine systems by using an adapter for snap lock chuck. 55 The patella surface is prepared using the patella reamer (f). Reaming depth is verified by means of f the mechanical stop on the reamer. In addition, there are marking grooves at 2 mm intervals. The maximum reaming depth is reached when the reamer collar makes contact with the reaming guide (56). 56 27  Surgical Technique Fixation Hole Drilling If the saw blade resection option is selected, the g patella is to be fixed with the patella holding clamp as follows: • Insert the patella reaming guide into the patella holding clamp • Ratchet function “ON” • Clamp the patella firmly Insert the drilling guide (g) for the anchoring holes which corresponds to the chosen implant size into the reaming guide (57). 57 In doing so, ensure that the guide pin on the drilling h guide lies in the opening made for it in the reaming guide. Using the appropriately-sized patella drill (h), 6.5 mm drill through the drilling guide until stopped by the depth stop with the appropriately sized patella drill (58). 58 28 Surgical Technique Option: Final Assessment of Extension and Flexion Gap and Alignment of Axis After final preparation the final spacer according to the deter- mined femoral size is choosen and inserted. (59-a, 59-b). The axial alignment is evaluated in extension by means of the extramedullary alignment rod which is referring to the mechani- cal axis. 59-a 59-b 29  Surgical Technique Trial Reduction and Functional Test The femur trial is selected according to the resected femoral size and is positioned with the attachable handle and impactor (60). 60 Procedure for GEMINI PS The femur trial box PS is inserted into the femur trial (61) and fixed with the securing screw (62). Then the trial is positioned with the attachable handle and impactor. 61 62 In addition, the trial can be inserted into its final position using the driver (63). Then the securing holes are drilled with the 5.5 mm twist drill (64). A drill guide is applied for guiding the twist drill. 63 64 30 Surgical Technique The trial plateau is selected and used according to which type of prosthesis is chosen: Fixed Bearing CR (B), Fixed Bearing PS (C) or Mobile Bearing (A). The different heights are set by means of the shim (D) (65). Attention! Shims are availabe in 2 mm-steps, A marking shows total height: Height Marking + 2 mm 12 mm B + 4 mm 14 mm + 6 mm 16 mm + 8 mm 18 mm C Attention! C Trial plateaus together with tibial preparation plate imitate 10 mm height. For Mobile Bearing A it is D mandatory to assemble the shim (+2 mm) = 12 mm 65 Procedure: Mobile Bearing 1. Insert tibial trial plateau assembled with shim into tibial preparation plate. 2. Position femoral trial prosthesis. Fixed Bearing/Fixed Bearing PS 1. Position femoral trial prosthesis. 2. Insert tibial trail plateau (optinal with assembled shim) into tibial preparation plate. Note: There is a locking clip to lock the trial plateau with the tibial preparation plate during trial reduction (66-a). Then trial reduction is performed with the knee joint in extension 66-a and flexion, and the ligament tension is checked (66-b). Height correction: Fixed Bearing/Fixed Bearing PS For adjusting the height the trial plateau is removed. Then the shim assembled accordingly. Mobile Bearing For correction of pure plateau height at lying femoral trial prosthesis, the trial plateau must be used for Fixed Bearing. Note: Make sure that no bony structures (e.g., osteophytes) or tissue parts interfere with the movement. If necessary, rework the bone in the notch area, but especially on the dorsal condyles, using a small curved chisel. 66-b The trial implants are then removed again. 31  Surgical Technique Implantation Compatibility Table The following table shows (67) possible size combinations. Compatibility: Femoral/Tibial Components Femoral Components 1 1B 2 2A 2B 3 4 5 PE Articula- XX = unrestricted compatibility ting Surfaces 1 1B 2 2A/B 3 4 5 XX = recommended combination 1 XX X X – – – – – X = restricted compatibility, depending on the patient‘s 2 XX XX XX X X X – – Components soft tissue situation in relation 3 XX XX XX XX XX XX X – to the articulating surface 4 XX XX XX XX XX XX XX X – = prohibited combination Tibial 5 XX XX XX XX XX XX XX XX 67 Implantation Sequence Mobile Bearing 1 Assembly of Mobile PE Articulating Surface (refer to the compatibility table) with Mobile Tibial Component 2 Implantation of Tibial Component complete with PE Articulating Surface (refer to the compatibility table) 3 Implantation of Femoral Component Fixed Bearing / Fixed Bearing PS 1 Implantation of Fixed Tibial Component 2 Implantation of Femoral Component 3 Insertion of Fixed or Fixed PS PE Articulating Surface (refer to the compatibility table) 32 Surgical Technique Tibia Implant Overview: PE Articulating Surfaces Taper Cap + Mobile Fixed PS version Stem Extensions cemented/cementless Mobile Tibial components Fixed cemented/cementless 68 Optionally, a taper cap or stem extensions can be placed on the taper and fixed with a screw. The taper cap and the stem extensions are available in cemented and cementless versions (68). Note: If the tibial component with stem extension is used, ensure that the tibial medullary canal is suitably prepared prior to placement. Note: Installing taper cap or stem extension. The taper cap or stem extension is fixed primarily by taper clamping, and doubly secured with securing screws. Attention! A first stem securing screw (grub screw with point is already in place in the taper hole. The second securing screw is supplied, in sterile packaging, together with the tibial component. The taper cap or stem extension is selected according to the planned type of treatment, and is placed on the taper of the tibial component. When doing this, align the mark on the taper cap or stem extension with the mark on the taper of the tibial component. Then fix with a hammer blow (69). Note: Place gauze over the surface to protect it from the hammer blow. The first stem securing screw (grub screw with point) (70-a -1) is screwed in and tighten it strongly by hand. Then screw in the second securing screw (70-a -2, 70-b) 69 with flat point for double securing. Use screwdriver 319-540/00 (allen wrench 2.0 mm) for both securing screws. -1 -2 70-a 70-b 70-c 33  Surgical Technique Implantation: Mobile Bearing Cemented Tibial Component The bone cement is prepared following the specific manufacturer‘s instructions, and applied Select the appropriate Mobile Bearing PE Articular Surface (pay attention to compatibility chart page 33). Onto the surgical table, place the Mobile Bearing PE Articular Surface sideways in longitudinal direction and turn it 90° clockwise to lock it in its final position (71).The tibial component is then inserted into the resected tibia, and driven onto the resection surface of the tibial head with the impactor (72, 73). 71 Attention! Ensure that excess bone cement is completely removed and no loose bone cement particles remain, especially in the dorsal joint region. 72 Cementless Tibial Component The cementless tibial component is introduced directly into the resected tibia and driven onto the resection surface of the tibial head with the impactor. Note: For each type of fixation (cemented/cementless), only use the correspondingly marked implants. 73 34 Surgical Technique Cemented Femoral Component The femoral component is coupled with the attachable handle and impactor. After applying the bone cement, prepared according to the specific manufacturer‘s instructions, the femoral component is implanted. It is driven on with the attachable handle and impactor (74). To finish, the femoral component can be re-driven with the plastic impactor (75). 74 75 Important! Ensure that excess bone cement is completely removed and no loose bone cement particles remain, especially in the dorsal joint section. Cementless Femoral Component The cementless femoral component is coupled in the same way as described above for the cementable version, using the attachable handle and impactor. Positioning of the femoral component and implantation are performed with several measured but forceful hammer blows. 35  Surgical Technique Implantation: Fixed Bearing and Fixed Bearing PS Cemented Tibial Component Attention! The retaining screw for fixing the UHMWPE articulating surface has been screwed into the tibial component. It must not be removed for cementing. The bone cement is prepared following the specific manufacturer‘s instructions, and applied. The tibial metal tray is then inserted into the resected tibia, and struck onto the resection surface of the tibial head and driven on with the driver (76). Attention! Ensure that excess bone cement is completely re-moved and no loose bone cement particles remain, especially in the dorsal joint section (77). Cementless Tibial Component The cementless tibial component is introduced directly into the resected tibia and driven on. 76 77 Cemented Femoral Component The femoral component is coupled with the attachable handle and impactor. After applying the bone cement, prepared according to the specific manufacturer‘s instructions, the femoral component is implanted. It is driven on with the attachable handle and impactor (78). To finish, the femoral component can be re-driven with the plastic impactor (79). Attention! Ensure that excess bone cement is completely removed and no loose bone cement particles remain, especially in the dorsal 78 joint section. Cementless Femoral Component The cementless femoral component is coupled in the same way as described above for the cemented version, using the attachable handle and impactor. Positioning of the femoral component and implantation are performed with several measured but forceful hammer blows. 79 36 Surgical Technique PE Articulating Surface The holding screw is removed from the tibial component. The PE articulating surface (Fixed CR or PS) corresponding to the femoral component is selected and inserted. Ensure that the two securing pins on the bottom surface of the articulating surface are positioned in the recesses of the component. To finish, the PE articulating surface is fixed to the component using the retaining screw supplied together with the component (80+81). 80 81 Note: The plateau locking screw has a „self cutting thread“. While tightened the fixation hole of the PE articular surface will be deformed. In case the plateau locking screw will be released and needs to be refixed again it will not be securely locked. In such a situation a new PE articular surface has to be choosen. Patella Implantation The reaming guide is removed from the patella clamp. The polyethylene insert (I) is pressed into the patella pusher inserter (K) (82-a, 82-b) and the pusher inserter is then inserted into the patellar clamp (82-c). K I 82-a 82-b 82-c 37  Surgical Technique Following extensive rinsing and removal of all impe- ding soft tissue, the bone cement is applied to the back of the implant, and the implant is placed by hand and pressed on using the patella clamp with the pusher inserter (83). Caution! Prepare the bone cement according to the manu- facturer’s instructions. Ensure that excess bone cement is completely removed and that no loose particles of bone cement 83 remain in the joint. Functional Test Implanted femoral and tibial components (84-a, 84-b). The concluding functional test is designed to check that the components are correctly positioned in extension and flexion of the knee joint, and also to check for correct ligament tension. 84-a 84-b 38 Surgical Technique APPENDIX 1: Precision Tibial Resection Alignment The Precision Tibial Resectipon Alignment can be used either extramedullary or intramedullary. Extramedullary Alignment Overview of components: • EM Fixation Jig (85.1) 85.1 • EM Alignment Rod (85.2) • EM Alignment Guide (85.3) with a foot clamp 85.4 - silicone belt fixation (85.3 -a) - with spring fixation (85.3 -b) • Stylus with Guide (85.4) The stylus comes in the following versions with the following designations: - „12“ for GEMINI SL Mobile Bearing - „10“ for GEMINI SL Fixed CR and Fixed PS 85.6 - „2“ for GEMINI SL defect referencing 85.5-a 85.5-b • Tibial Base Guide (85.5) The tibial base guide consists of tibial cutting block holder (85.5-a) and tibial base guide body (85.5-b). 85.2 The tibial base guide allows fine tuning of varus-valgus, posterior slope and resection level. • Tibial Cutting Block (85.6) - Symmetrical - Asymmetrical (medial approach), left - Asymmetrical (medial approach), right 85.3 85.3-a 85.3-b 39  Surgical Technique Assembly Compponents are assembled accordingly: Step 1: 3. First the tibial cutting jig is assembled. 85.4 According to the preferred technique the tibial cutting block (85.6) is determined (symmetrical or asymmetrical). The tibial cutting block is mounted with the tibial cutting block holder (85.5 -a) and then connected with the tibial base guide body (85.5 -b). Release the locking screw at the stylus guide then insert the foot of the stylus guide (85.4) into the attachment 2. of the tibial cutting block. 1. 85.6 85.5 -a 85.5 -b Note: Preselect varus/valgus adjustment to „0“ and posterior slope to „5°“.The device allows fine tuning of the adjustment after the tibial cutting jig has been fixed 85.1 to the tibia. Step 2: The EM alignment rod (85.2) is assembled with the EM fixation jig (85.1) and then pushed through the tibial base guide of the tibial cutting jig. Proximal tibial cutting jig (85.7). 85.2 Step 3: Insert the foot clamp (85.3-a) into the alignment guide (85.3) and hand-tighten the locking screw (A). 85.3 85.7 A 85.3-a 40 Surgical Technique Positioning Attach the foot clamp to the ankle joint and secure with the silicone belt (87-a). Option: The foot clamp can be choosen either spring clamp ot silicone belt. The EM orientation rod with the fixation jig (86.7) is inserted through the tibial base guide (86.3) and into the distal guide tube, and is secured with the connecting sleeve (87-b). 86.7 Note: The connecting sleeve secures the proximal tibial cutting jig of anaterior release. The cutting jig can still be moved proximal/ distal. 87-a 86.3 87-b Proximal, the tip of the fixation jig initially rests in the area of the point of attachment of the anterior cruciate ligament, roughly centrally in the region of the intercondylar eminence on the tibial plateau (88-a). Then the tip is knocked in with a hammer (88-b). The alignment instru- ment can still be rotated. 88-b 88-a 41  Surgical Technique Rotation Definition and Axial Alignment To determine the correct alignment of the rotation, the alignment instrument is aligned centrally along the tibial shaft axis (89-a). Note: For assistance, the center of the tibia, the tibial tuberosity and the second toe can be marked with a sterile marker pen. When the alignment instrument, viewed from the side, is parallel to the ventral tibia, this means that the saw guide is set in the previously selected posterior slope. Fine adjustment is possible following alignment (89-b). 89-a 89-b Then secure the tibial resection alignment proximal with two drill pins through the dedicated holes of the tibial base guide (90-a, 90-b). 90-a 90-b 42 Surgical Technique Resection Adjustment The EM fixation jig and the stylus are removed and the EM Alignment Rod ist slided distal into the EM Alignment Guide allowing now for micro adjustment of the tibial resection. Fine Tuning for the Tibial Resection Correct alignment can be checked using the cutting template (91). Posterior Slope GEMINI SL Tibia Slope Recommendations: For a Mobile Bearing and 91 Fixed Bearing Cruciate Retaining (CR) configuration it is recommended to set the tibial posterior slope at 5 degrees. For a Fixed Bearing Posterior Stabilized (PS) configuration, a range of 0 – 5 degrees of tibial posterior slope is recommended. Posterior slope can be adjusted in 1° steps with the micro adjustment (A) (92). Tibial Resection Height After presetting the resection height with the selected stylus version, the resection hight can now be micro adjusted with the screw (C) (92). A B C 92 Varus-valgus Adjustment The micro adjustment (B) allows precise correction of the varus or valgus alignment.The alignment can be checked by inserting the EM alignment rod (93). Then the tibial cutting block is fixed with a drill pin (94-a) and the resection is performed (94-b). The cross-pin of the tibial cutting block is removed. B The fixation of the ankle clamp is taken off then the alignment device is re- moved leaving the two pins in place which will allow a simple repositioning if re-resection is necessary. 94-a 94-b 93 43  Surgical Technique APPENDIX 2: Precision Tibial Resection Alignment Intramedullary Alignment Overview of the components: • IM Fixation Jig (95.1) • EM Alignment Rod (95.2) 95.6 • Stylus with Guide (95.3) The stylus comes in the following versions 95.1 with the following designations: - „12“ for GEMINI SL Mobile Bearing - „10“ for GEMINI SL Fixed and Fixed PS - „2“ for GEMINI SL defect referencing • Tibial Cutting Block (95.4) 95.3 - Symmetrical - Asymmetrical (medial approach), left - Asymmetrical (medial approach), right 95.5 -b 95.7 95.5 -a • Tibial Base Guide (95.5) The tibial base guide consists of tibial cutting 95.4 95.2 block holder (95.5-a) and tibial base guide body (95.5-b).The tibial base guide allows fine tuning of varus-valgus, posterior slope and resection level. • T-Handle (95.6) • IM Guide Rod (95.7) 44 Surgical Technique Assembly: 95.3 Step 1: 3. First the tibial cutting jig is assembled. According to the preferred technique the tibial cutting block (95.4) is determined (symmetrical or asymmetrical). The tibial cutting block is mounted with the varus/valgus adjustment (95.5 -a) and then connected with the tibial base guide (95.5 -b). Release the locking screw at the stylus guide then insert the foot of the stylus guide (95.3) 2. into the attachment of the tibial cutting block. 1. 95.4 95.5-a 95.5 -b Note: Preselect varus/valgus adjustment to „0“ and posterior slope to „5°“. The device allows micro tuning of the adjustment after the tibial cutting jig has been fixed to the tibia. 96.1 Step 2: 96.2 The EM alignment rod (96.2) is assembled with the IM fixation jig (96.1) and then pushed through the tibial base guide of the tibial cutting jig (97-a, 97-b). Proximal tibial cutting jig. 97-a 97-b 45  Surgical Technique Positioning The entrance to the meduallary canal is opened using the step drill having a pilot tip (98). 98 Connect the T-Handle with the IM guide rod (99-a). Insert the IM guide rod carefully into the tibial canal until the isthmus is firmly engaged (99-b) 99-b 99-a 46 Surgical Technique The T-Handle is removed. The previously assembled tibial cutting jig is postioned on the IM guide rod until the tip of the stylus rests on the tibial plateau (100-a, 100-b). Rotation Definition and Axial Alignment To determine the correct alignment of the rotation, the alignment instrument is aligned centrally along the tibial shaft axis (100-a). When the alignment instrument, viewed from the side, is parallel to the anterior tibia, this means that the sawguide is set in the previously selected posterior slope. Fine tuning is possible following alignment (100-b). 100-b 100-a Determination of Resection Height The resection height is determined using the stylus according to preferred referencing. Then secure the tibial cutting jig anterior with two drill pins through the dedicated holes of the tibial base guide (101-a, 101-b). Connect the T-Handle with the IM guide rod and remove the IM guide rod. 101-b 101-a 47  Surgical Technique Resection Adjustment The IM fixation jig and the stylus with guide are removed and the EM alignment rod is pushed distal into the tibaoil base guide. Fine Tuning for the Tibial Resection The tibial saw guide is now pushed against the anterior tibial cortical bone as far as the limit stop. Correct alignment can be checked using the cutting template (102). Posterior Slope 102 GEMINI SL: Tibia Slope Recommendations: For Mobile Bearing and Fixed Bearing Cruciate Retaining (CR) configuration it is recom- mended to set the tibial posterior slope at 5 degrees. For a Fixed Bearing Pos-terior Stabilized (PS) configuration, a range of 0 – 5 degrees of tibial posterior slope is recommended. Posterior slope can be adjusted in 1° steps with the fine tuning (A) (103). Tibial Resection Height After presetting the resection height with the selected stylus version, A the resection hight can now be fine tuned with the screw (C) (103). B Varus-valgus Adjustment The fine tuning (B) allows precise correction of the varus or valgus C 103 alignment (103).The alignment can be checked by inserting the EM alignment rod (104). Then the tibial cutting block is fixed with a drill pin (105-a) and the B resection is performed (105-b). 105-a 105-b 104 48 Surgical Technique APPENDIX 3: GEMINI SL EXTRABONE – Extramedullary Femoral Referencing Preoperative Planning With EXTRABONE, the position and alignment of the distal femoral resection plane are planned on the A/P femoral X-ray. A special X-ray template (106) is available for this purpose. The long axis is aligned to the head of the femur. The short axis is applied tangentially to the widest point of the distal femoral condyle.Then the distance to the shorter femoral condyle is determined as the difference. In the example (107-a, 107-b), there is a 2 mm of set between the medial and lateral femoral condyles. With this method, the cartilage layer is not taken into account, as it is not visualized by the imaging technique. Therefore the cartilage layer has to be removed intraoperatively in order to create the same preoperative condition. Note: The basis for a correct technique is accurate preplanning based on a X-ray of the total femur. 106 107-b 107-a As the cartilage was not taken into account in the preceding radiological planning, the cartilage layer – if still present – has to be removed (108). 108 49  Surgical Technique Femur Preparation – Distal Resection With EXTRABONE, extramedullary referencing for the distal femoral resection is performed as follows. The GEMINI SL femoral component permits size-specific distal resection: Sizes 1-2B distal femoral cutting block "S" Sizes 3-5 distal femoral cutting block "L" The femoral sizer is used to verify the femoral size determined in preoperative planning and to select the distal femoral cutting block (109, 109-a, 109-b). The sizer is held against the femur to determine its size. The contour shown below corresponds to size 3. If the femur profile is smaller, the distal cutting block "S" should be selected. If the femur profile is a perfect fit or larger, the distal cutting block "L" should be selected. The m/l dimension can be checked in addition. Size > = L m/l 109 m/l 109-a 109-b The guide for flexion/extension alignment is placed on the anterior bone (110, 110-a, 110-b). 110 110-a 110-b 50 Surgical Technique The positioner guide is placed vertically onto the guide and fixed with two drill pins (111, 111-a,111-b,111-c). 111 111-a 111-b 111-c The alignment instrument for holding the distal cutting block is attached with the connection piece (112) and inserted into the positioner guide (112-a). The alignment instrument is inserted far enough that the two condyle stop plates rest against the distal medial and lateral femoral condyles (112-b). The condyle stop plates can be swiveled from 0° to 25° to ensure that they are precisely positioned. 112-a 112 112-b 51  Surgical Technique The alignment instrument has a setting screw and scale medially and laterally (113) for transferring the preoperative planning data for the offset of the distal femoral condyles to the distal femur. The varus/valgus orientation of the resection is achieved by adjusting the condyle stop plates with the medial and lateral setting screws. This alignment can be verified intraoperatively with the axial alignment guide and an alignment rod (114). 113 114 Two drill pins are positioned for referencing the position of the distal femoral cutting block. The distal femoral cutting block is positioned over these two drill pins, taking into account the previously determined size ("S" or "L") (115). 115 The cutting template can be used to check the alignment of the distal resection (116). 116 52 Surgical Technique To make the cutting block more stable, a third drill pin is fixed into the lateral diagonal hole. There is the option of inserting a fourth drill pin (117). 117 The distal saw cut is made at 90° flexion (118). 118 The parallel drill pins remain in position (119). Note: It is possible to adjust the extension gap by repeating the resection. 119 The rest of the procedure is performed in the same way as with the standard surgical technique GEMINI SL Total Knee System. 53  Implants GEMINI SL Femoral Components – Fixed Bearing CR / Mobile Bearing to be used with Fixed Bearing CR and Mobile Bearing PE Articulating Surfaces cemented CoCrMo CoCrMo CoCrMo/TiNbN SMS* SpheroGrip SMS*/LINK PorEx ** A B Identi- Size Side mm mm fication 318-102/01 318-402/01 318-206/01 x-small right 52 55 R1 318-102/16 318-402/16 318-206/16 x-small plus right 55 62 R1B 318-102/02 318-402/02 318-206/02 small right 59 62 R2 318-102/25 318-402/25 318-206/25 medium small right 59 69 R2A 318-102/26 318-402/26 318-206/26 medium small plus right 62 69 R2B 318-102/03 318-402/03 318-206/03 medium right 65 69 R3 318-102/04 318-402/04 318-206/04 large right 67 72 R4 318-102/05 318-402/05 318-206/05 x-large right 72 76 R5 318-103/01 318-403/01 318-207/01 x-small left 52 55 L1 318-103/16 318-403/16 318-207/16 x-small plus left 55 62 L1B 318-103/02 318-403/02 318-207/02 small left 59 62 L2 318-103/25 318-403/25 318-207/25 medium small left 59 69 L2A 318-103/26 318-403/26 318-207/26 medium small plus left 62 69 L2B 318-103/03 318-403/03 318-207/03 medium left 65 69 L3 318-103/04 318-403/04 318-207/04 large left 67 72 L4 318-103/05 318-403/05 318-207/05 x-large left 72 76 L5 cementless CoCrMo/TiCaP*** CoCrMo/TiNbN/TiCaP*** SMS* SMS*/LINK PorEx ** A B Identi- Size Side mm mm fication 318-204/01 318-208/01 x-small right 52 55 R1 318-204/16 318-208/16 x-small plus right 55 62 R1B 318-204/02 318-208/02 small right 59 62 R2 318-204/25 318-208/25 medium small right 59 69 R2A 318-204/26 318-208/26 medium small plus right 62 69 R2B 318-204/03 318-208/03 medium right 65 69 R3 318-204/04 318-208/04 large right 67 72 R4 318-204/05 318-208/05 x-large right 72 76 R5 318-205/01 318-209/01 x-small left 52 55 L1 318-205/16 318-209/16 x-small plus left 55 62 L1B 318-205/02 318-209/02 small left 59 62 L2 318-205/25 318-209/25 medium small left 59 69 L2A 318-205/26 318-209/26 medium small plus left 62 69 L2B 318-205/03 318-209/03 medium left 65 69 L3 318-205/04 318-209/04 large left 67 72 L4 318-205/05 318-209/05 x-large left 72 76 L5 * SMS: Squarical Monobloc Structure. ** LINK PorEx: TiNbN = Titanium Niobium Nitride; hypoallergenic coating (gold color). *** TiCaP double coating: Titan/Calcium Phosphate (CaP). 54 Implants GEMINI SL Femoral Components – Fixed Bearing PS to be used with Fixed Bearing PS PE Articulating Surfaces cemented CoCrMo CoCrMo CoCrMo/TiNbN SMS* SpheroGrip SMS*/LINK PorEx ** A B Identi- Size Side mm mm fication 318-112/01 318-412/01 318-214/01 x-small right 52 55 R1 318-112/16 318-412/16 318-214/16 x-small plus right 55 62 R1B 318-112/02 318-412/02 318-214/02 small right 59 62 R2 318-112/25 318-412/25 318-214/25 medium small right 59 69 R2A 318-112/26 318-412/26 318-214/26 medium small plus right 62 69 R2B 318-112/03 318-412/03 318-214/03 medium right 65 69 R3 318-112/04 318-412/04 318-214/04 large right 67 72 R4 318-112/05 318-412/05 318-214/05 x-large right 72 76 R5 318-113/01 318-413/01 318-215/01 x-small left 52 55 L1 318-113/16 318-413/16 318-215/16 x-small plus left 55 62 L1B 318-113/02 318-413/02 318-215/02 small left 59 62 L2 318-113/25 318-413/25 318-215/25 medium small left 59 69 L2A 318-113/26 318-413/26 318-215/26 medium small plus left 62 69 L2B 318-113/03 318-413/03 318-215/03 medium left 65 69 L3 318-113/04 318-413/04 318-215/04 large left 67 72 L4 318-113/05 318-413/05 318-215/05 x-large left 72 76 L5 cementless CoCrMo/TiCaP*** CoCrMo/TiNbN/TiCaP*** SMS* SMS*/LINK PorEx ** A B Identi- Size Side mm mm fication 318-212/01 318-216/01 x-small right 52 55 R1 318-212/16 318-216/16 x-small plus right 55 62 R1B 318-212/02 318-216/02 small right 59 62 R2 318-212/25 318-216/25 medium small right 59 69 R2A 318-212/26 318-216/26 medium small plus right 62 69 R2B 318-212/03 318-216/03 medium right 65 69 R3 318-212/04 318-216/04 large right 67 72 R4 318-212/05 318-216/05 x-large right 72 76 R5 318-213/01 318-217/01 x-small left 52 55 L1 318-213/16 318-217/16 x-small plus left 55 62 L1B 318-213/02 318-217/02 small left 59 62 L2 318-213/25 318-217/25 medium small left 59 69 L2A 318-213/26 318-217/26 medium small plus left 62 69 L2B 318-213/03 318-217/03 medium left 65 69 L3 318-213/04 318-217/04 large left 67 72 L4 318-213/05 318-217/05 x-large left 72 76 L5 * SMS: Squarical Monobloc Structure. ** LINK PorEx: TiNbN = Titanium Niobium Nitride; hypoallergenic coating (gold color). *** TiCaP double coating: Titan/Calcium Phosphate (CaP). 55  Implants GEMINI SL Tibial Components – Fixed Bearing to be used with Fixed Bearing CR and PS PE Articulating Surfaces cemented Taper 10/12 mm CoCrMo CoCrMo CoCrMo/TiNbN SMS* SpheroGrip SMS*/LINK PorEx ** A B Identi- Size Side mm mm fication 318-372/01 318-482/01 318-328/01 x-small right 42 62 R1 318-372/02 318-482/02 318-328/02 small right 46 69 R2 318-372/03 318-482/03 318-328/03 medium right 47 74 R3 318-372/04 318-482/04 318-328/04 large right 53 78 R4 318-372/05 318-482/05 318-328/05 x-large right 56 85 R5 318-373/01 318-483/01 318-329/01 x-small left 42 62 L1 318-373/02 318-483/02 318-329/02 small left 46 69 L2 318-373/03 318-483/03 318-329/03 medium left 47 74 L3 318-373/04 318-483/04 318-329/04 large left 53 78 L4 318-373/05 318-483/05 318-329/05 x-large left 56 85 L5 incl. Locking Screw for PE Articulating Surface cementless Taper 10/12 mm CoCrMo/TiCaP*** CoCrMo/TiNbN/TiCaP*** SMS* SMS*/LINK PorEx ** A B Identi- Size Side mm mm fication 318-376/01 318-336/01 x-small right 42 62 R1 318-376/02 318-336/02 small right 46 69 R2 318-376/03 318-336/03 medium right 47 74 R3 318-376/04 318-336/04 large right 53 78 R4 318-376/05 318-336/05 x-large right 56 85 R5 318-377/01 318-337/01 x-small left 42 62 L1 318-377/02 318-337/02 small left 46 69 L2 318-377/03 318-337/03 medium left 47 74 L3 318-377/04 318-337/04 large left 53 78 L4 318-377/05 318-337/05 x-large left 56 85 L5 incl. Locking Screw for PE Articulating Surface * SMS: Squarical Monobloc Structure. ** LINK PorEx: TiNbN = Titanium Niobium Nitride; hypoallergenic coating (gold color). *** TiCaP double coating: Titan/Calcium Phosphate (CaP). 56 Implants GEMINI SL Tibial Components – Mobile Bearing to be used with Mobile Bearing PE Articulating Surfaces cemented Taper 10/12 mm CoCrMo CoCrMo CoCrMo/TiNbN SMS* SpheroGrip SMS*/LINK PorEx ** A B Identi- Size Side mm mm fication 318-312/01 318-452/01 318-324/01 x-small right 42 62 R1 318-312/02 318-452/02 318-324/02 small right 46 69 R2 318-312/03 318-452/03 318-324/03 medium right 47 74 R3 318-312/04 318-452/04 318-324/04 large right 53 78 R4 318-312/05 318-452/05 318-324/05 x-large right 56 85 R5 318-313/01 318-453/01 318-325/01 x-small left 42 62 L1 318-313/02 318-453/02 318-325/02 small left 46 69 L2 318-313/03 318-453/03 318-325/03 medium left 47 74 L3 318-313/04 318-453/04 318-325/04 large left 53 78 L4 318-313/05 318-453/05 318-325/05 x-large left 56 85 L5 cementless Taper 10/12 mm CoCrMo/TiCaP*** CoCrMo/TiNbN/TiCaP*** SMS* SMS*/LINK PorEx ** A B Identi- Size Side mm mm fication 318-316/01 318-326/01 x-small right 42 62 R1 318-316/02 318-326/02 small right 46 69 R2 318-316/03 318-326/03 medium right 47 74 R3 318-316/04 318-326/04 large right 53 78 R4 318-316/05 318-326/05 x-large right 56 85 R5 318-317/01 318-327/01 x-small left 42 62 L1 318-317/02 318-327/02 small left 46 69 L2 318-317/03 318-327/03 medium left 47 74 L3 318-317/04 318-327/04 large left 53 78 L4 318-317/05 318-327/05 x-large left 56 85 L5 * SMS: Squarical Monobloc Structure. ** LINK PorEx: TiNbN = Titanium Niobium Nitride; hypoallergenic coating (gold color). *** TiCaP double coating: Titan/Calcium Phosphate (CaP). 57  Implants GEMINI SL Tibial Components – Fixed Bearing CR to be used with Femoral Components CR (Cruciate Retaining) and Fixed Bearing Tibial Components Fixed Bearing CR - PE Articulating Surfaces UHMWPE Size Side H h A B Identi- mm mm mm mm fication 318-231/10 x-small right 10 6 42 62 R1 318-238/10 x-small plus right 10 6 46 69 R1B 318-232/10 small right 10 6 46 69 R2 318-237/10 medium small / medium small plus right 10 6 47 74 R2A / R2B 318-233/10 medium right 10 6 47 74 R3 318-234/10 large right 10 6 53 78 R4 318-235/10 x-large right 10 6 56 85 R5 318-241/10 x-small left 10 6 42 62 L1 318-248/10 x-small plus left 10 6 46 69 L1B 318-242/10 small left 10 6 46 69 L2 318-247/10 medium small / medium small plus left 10 6 47 74 L2A / L2B 318-243/10 medium left 10 6 47 74 L3 318-244/10 large left 10 6 53 78 L4 318-245/10 x-large left 10 6 56 85 L5 318-231/12 x-small right 12 8 42 62 R1 318-238/12 x-small plus right 12 8 46 69 R1B 318-232/12 small right 12 8 46 69 R2 318-237/12 medium small / medium small plus right 12 8 47 74 R2A / R2B 318-233/12 medium right 12 8 47 74 R3 318-234/12 large right 12 8 53 78 R4 318-235/12 x-large right 12 8 56 85 R5 318-241/12 x-small left 12 8 42 62 L1 318-248/12 x-small plus left 12 8 46 69 L1B 318-242/12 small left 12 8 46 69 L2 318-247/12 medium small / medium small plus left 12 8 47 74 L2A / L2B 318-243/12 medium left 12 8 47 74 L3 318-244/12 large left 12 8 53 78 L4 318-245/12 x-large left 12 8 56 85 L5 318-231/14 x-small right 14 10 42 62 R1 318-238/14 x-small plus right 14 10 46 69 R1B 318-232/14 small right 14 10 46 69 R2 318-237/14 medium small / medium small plus right 14 10 47 74 R2A / R2B 318-233/14 medium right 14 10 47 74 R3 318-234/14 large right 14 10 53 78 R4 318-235/14 x-large right 14 10 56 85 R5 Further implant sizes on next page... 58 Implants Fixed Bearing CR - PE Articulating Surfaces UHMWPE H h A B Identi- Size Side mm mm mm mm fication 318-241/14 x-small left 14 10 42 62 L1 318-248/14 x-small plus left 14 10 46 69 L1B 318-242/14 small left 14 10 46 69 L2 318-247/14 medium small / medium small plus left 14 10 47 74 L2A / L2B 318-243/14 medium left 14 10 47 74 L3 318-244/14 large left 14 10 53 78 L4 318-245/14 x-large left 14 10 56 85 L5 318-231/16 x-small right 16 12 42 62 R1 318-238/16 x-small plus right 16 12 46 69 R1B 318-232/16 small right 16 12 46 69 R2 318-237/16 medium small / medium small plus right 16 12 47 74 R2A / R2B 318-233/16 medium right 16 12 47 74 R3 318-234/16 large right 16 12 53 78 R4 318-235/16 x-large right 16 12 56 85 R5 318-241/16 x-small left 16 12 42 62 L1 318-248/16 x-small plus left 16 12 46 69 L1B 318-242/16 small left 16 12 46 69 L2 318-247/16 medium small / medium small plus left 16 12 47 74 L2A / L2B 318-243/16 medium left 16 12 47 74 L3 318-244/16 large left 16 12 53 78 L4 318-245/16 x-large left 16 12 56 85 L5 318-231/18 x-small right 18 14 42 62 R1 318-238/18 x-small plus right 18 14 46 69 R1B 318-232/18 small right 18 14 46 69 R2 318-237/18 medium small / medium small plus right 18 14 47 74 R2A / R2B 318-233/18 medium right 18 14 47 74 R3 318-234/18 large right 18 14 53 78 R4 318-235/18 x-large right 18 14 56 85 R5 318-241/18 x-small left 18 14 42 62 L1 318-248/18 x-small plus left 18 14 46 69 L1B 318-242/18 small left 18 14 46 69 L2 318-247/18 medium small / medium small plus left 18 14 47 74 L2A / L2B 318-243/18 medium left 18 14 47 74 L3 318-244/18 large left 18 14 53 78 L4 318-245/18 x-large left 18 14 56 85 L5 59  Implants GEMINI SL Tibial Components – Fixed Bearing PS to be used with Femoral Components PS (Posterior Stabilized) and Fixed Bearing Tibial Components Fixed Bearing PS - PE Articulating Surfaces UHMWPE H h A B Identi- Size Side mm mm mm mm fication 318-251/10 x-small right 10 6 42 62 R1 318-258/10 x-small plus right 10 6 46 69 R1B 318-252/10 small right 10 6 46 69 R2 318-256/10 medium small / medium small plus right 10 6 47 74 R2A / R2B 318-253/10 medium right 10 6 47 74 R3 318-254/10 large right 10 6 53 78 R4 318-255/10 x-large right 10 6 56 85 R5 318-261/10 x-small left 10 6 42 62 L1 318-268/10 x-small plus left 10 6 46 69 L1B 318-262/10 small left 10 6 46 69 L2 318-266/10 medium small / medium small plus left 10 6 47 74 L2A / L2B 318-263/10 medium left 10 6 47 74 L3 318-264/10 large left 10 6 53 78 L4 318-265/10 x-large left 10 6 56 85 L5 318-251/12 x-small right 12 8 42 62 R1 318-258/12 x-small plus right 12 8 46 69 R1B 318-252/12 small right 12 8 46 69 R2 318-256/12 medium small / medium small plus right 12 8 47 74 R2A / R2B 318-253/12 medium right 12 8 47 74 R3 318-254/12 large right 12 8 53 78 R4 318-255/12 x-large right 12 8 56 85 R5 318-261/12 x-small left 12 8 42 62 L1 318-268/12 x-small plus left 12 8 46 69 L1B 318-262/12 small left 12 8 46 69 L2 318-266/12 medium small / medium small plus left 12 8 47 74 L2A / L2B 318-263/12 medium left 12 8 47 74 L3 318-264/12 large left 12 8 53 78 L4 318-265/12 x-large left 12 8 56 85 L5 Further implant sizes on next page... 60 Implants Fixed Bearing PS - PE Articulating Surfaces UHMWPE H h A B Identi- Size Side mm mm mm mm fication 318-251/14 x-small right 14 10 42 62 R1 318-258/14 x-small plus right 14 10 46 69 R1B 318-252/14 small right 14 10 46 69 R2 318-256/14 medium small / medium small plus right 14 10 47 74 R2A / R2B 318-253/14 medium right 14 10 47 74 R3 318-254/14 large right 14 10 53 78 R4 318-255/14 x-large right 14 10 56 85 R5 318-261/14 x-small left 14 10 42 62 L1 318-268/14 x-small plus left 14 10 46 69 L1B 318-262/14 small left 14 10 46 69 L2 318-266/14 medium small / medium small plus left 14 10 47 74 L2A / L2B 318-263/14 medium left 14 10 47 74 L3 318-264/14 large left 14 10 53 78 L4 318-265/14 x-large left 14 10 56 85 L5 318-251/16 x-small right 16 12 42 62 R1 318-258/16 x-small plus right 16 12 46 69 R1B 318-252/16 small right 16 12 46 69 R2 318-256/16 medium small / medium small plus right 16 12 47 74 R2A / R2B 318-253/16 medium right 16 12 47 74 R3 318-254/16 large right 16 12 53 78 R4 318-255/16 x-large right 16 12 56 85 R5 318-261/16 x-small left 16 12 42 62 L1 318-268/16 x-small plus left 16 12 46 69 L1B 318-262/16 small left 16 12 46 69 L2 318-266/16 medium small / medium small plus left 16 12 47 74 L2A / L2B 318-263/16 medium left 16 12 47 74 L3 318-264/16 large left 16 12 53 78 L4 318-265/16 x-large left 16 12 56 85 L5 318-251/18 x-small right 18 14 42 62 R1 318-258/18 x-small plus right 18 14 46 69 R1B 318-252/18 small right 18 14 46 69 R2 318-256/18 medium small / medium small plus right 18 14 47 74 R2A / R2B 318-253/18 medium right 18 14 47 74 R3 318-254/18 large right 18 14 53 78 R4 318-255/18 x-large right 18 14 56 85 R5 318-261/18 x-small left 18 14 42 62 L1 318-268/18 x-small plus left 18 14 46 69 L1B 318-262/18 small left 18 14 46 69 L2 318-266/18 medium small / medium small plus left 18 14 47 74 L2A / L2B 318-263/18 medium left 18 14 47 74 L3 318-264/18 large left 18 14 53 78 L4 318-265/18 x-large left 18 14 56 85 L5 61  Implants GEMINI SL Tibial Components – Mobile Bearing to be used with Femoral Components CR (Cruciate Retaining) and Mobile Bearing Tibial Components Mobile Bearing - PE Articulating Surfaces UHMWPE H h A B Identi- Size Side mm mm mm mm fication 318-431/12 x-small right 12 5 42 62 R1 318-438/12 x-small plus right 12 5 46 69 R1B 318-432/12 small right 12 5 46 69 R2 318-437/12 medium small / medium small plus right 12 5 47 74 R2A / R2B 318-433/12 medium right 12 5 47 74 R3 318-434/12 large right 12 5 53 78 R4 318-435/12 x-large right 12 5 56 85 R5 318-441/12 x-small left 12 5 42 62 L1 318-448/12 x-small plus left 12 5 46 69 L1B 318-442/12 small left 12 5 46 69 L2 318-447/12 medium small / medium small plus left 12 5 47 74 L2A / L2B 318-443/12 medium left 12 5 47 74 L3 318-444/12 large left 12 5 53 78 L4 318-445/12 x-large left 12 5 56 85 L5 318-431/14 x-small right 14 7 42 62 R1 318-438/14 x-small plus right 14 7 46 69 R1B 318-432/14 small right 14 7 46 69 R2 318-437/14 medium small / medium small plus right 14 7 47 74 R2A / R2B 318-433/14 medium right 14 7 47 74 R3 318-434/14 large right 14 7 53 78 R4 318-435/14 x-large right 14 7 56 85 R5 318-441/14 x-small left 14 7 42 62 L1 318-448/14 x-small plus left 14 7 46 69 L1B 318-442/14 small left 14 7 46 69 L2 318-447/14 medium small / medium small plus left 14 7 47 74 L2A / L2B 318-443/14 medium left 14 7 47 74 L3 318-444/14 large left 14 7 53 78 L4 318-445/14 x-large left 14 7 56 85 L5 318-431/16 x-small right 16 9 42 62 R1 318-438/16 x-small plus right 16 9 46 69 R1B 318-432/16 small right 16 9 46 69 R2 318-437/16 medium small / medium small plus right 16 9 47 74 R2A / R2B 318-433/16 medium right 16 9 47 74 R3 318-434/16 large right 16 9 53 78 R4 318-435/16 x-large right 16 9 56 85 R5 Further implant sizes on next page... 62 Implants Mobile Bearing - PE Articulating Surfaces UHMWPE H h A B Identi- Size Side mm mm mm mm fication 318-441/16 x-small left 16 9 42 62 L1 318-448/16 x-small plus left 16 9 46 69 L1B 318-442/16 small left 16 9 46 69 L2 318-447/16 medium small / medium small plus left 16 9 47 74 L2A / L2B 318-443/16 medium left 16 9 47 74 L3 318-444/16 large left 16 9 53 78 L4 318-445/16 x-large left 16 9 56 85 L5 318-431/18 x-small right 18 11 42 62 R1 318-438/18 x-small plus right 18 11 46 69 R1B 318-432/18 small right 18 11 46 69 R2 318-437/18 medium small / medium small plus right 18 11 47 74 R2A / R2B 318-433/18 medium right 18 11 47 74 R3 318-434/18 large right 18 11 53 78 R4 318-435/18 x-large right 18 11 56 85 R5 318-441/18 x-small left 18 11 42 62 L1 318-448/18 x-small plus left 18 11 46 69 L1B 318-442/18 small left 18 11 46 69 L2 318-447/18 medium small / medium small plus left 18 11 47 74 L2A / L2B 318-443/18 medium left 18 11 47 74 L3 318-444/18 large left 18 11 53 78 L4 318-445/18 x-large left 18 11 56 85 L5 Femoral Component Polyethylene Articula- ting Surfaces (Mobile) Tibial Component (Mobile) 63  Implants GEMINI SL Total Knee Replacement Taper Caps with LINK PorEx (TiNbN = Titanium Niobium Nitride) available as custom-made implant on request. Taper Caps for Tibial Components cemented The taper of the tibial component for coupling with modular stems CoCrMo can be covered with the taper cap, thus providing a short prosthesis 318-314 Ø 16 mm, length (L) 28 mm stem (overall length = 49 mm). The cap is fixed to the taper by cementless means of a hex screw using a hex screwdriver (hex. 2.0 mm). CoCrMo/TiCaP * The cap is provided separately in sterile packaging. 318-314/01 Ø 16 mm, length (L) 28 mm Ti6Al4V (Tilastan) 318-315 Ø 16 mm, length (L) 28 mm * TiCaP double coating: Titan (Ti)/Calcium Phosphate (CaP) Ø Patella Resurfacing Components, 3-pegs H UHMWPE Ø Height Size mm mm 318-401/25 1 25 7 318-401/28 2 28 8 318-401/31 3 31 9 318-401/34 4 34 10 Instrument Set for Patella Components are available on request. 64 Implants ØD Tibial Stems Ti6Al4V (Tilastan) ØB cemented L ØA ØB ØD L LT mm mm mm mm mm 318-190/07 7 10 16 50 70 318-190/10 7 10 16 80 100 318-190/14 7 10 16 120 140 ØA Tibial Stems Ti6Al4V (Tilastan) ØD cementless ØA ØB ØD L LT ØB mm mm mm mm mm L 318-191/07 10 16 16 50 70 318-191/10 10 16 16 80 100 318-191/14 10 16 16 120 140 ØA LT 65  Instruments GEMINI SL Instrument Set – Overview GEMINI SL Instrument Sets 319-011/31 Case 1 SIT-CUT Easy Tibia Resection Alignment 319-020/31 Case 2 Femoral Preparation 319-030/31 Case 3 Spacer 319-040/31 Case 4 Tibia Preparation 445-008/00 Case 5 Femoral Trial Prostheses 319-060/32 Case 6 Femoral PS Preparation 319-070/31 Case 7 General Instruments 319-080/31 Case 8 Final Spacer 340-200/01 Patella Instrument Set Additional Instrument Sets: 319-010/31 Precision Tibia Resection Alignment 317-800/00 EXTRABONE Instrument Set 66 Instruments 319-011/31 Case 1 – SIT-CUT Easy Tibia Resection Alignment 1 2 3 4 5 6 13 14 7 8 9 12 10 11 15 1 319-611/31 Instrument Tray 1B, empty, 485 x 253 x 100 mm (incl. lid) 2 319-180/01 EM Alignment Rod 3 319-182/00 Foot Clamp, silicon belt connection 4 319-181/01 EM Alignment Guide 5 319-525/00 Alignment Rod, extramedullary 6 319-520/01 Alignment Rod, extramedullary 7 319-125/01 Stylus, Referencer Defect Compartment (2 mm) 8 319-130/01 Stylus, Referencer Intact Compartment (10 mm) 9 319-135/01 Stylus, Referencer Intact Compartment (12 mm) 10 319-185/00 Cutting Block, Tibial Plateau, symmetrical, right and left 11 319-186/00 Cutting Block, Tibial Plateau, asymmetrical, left 12 319-187/00 Cutting Block, Tibial Plateau, asymmetrical, right 13 319-184/00 Stylus Guide 14 319-183/00 Foot Clamp, spring fixation 15 317-538/01 Plastic Connector * * without illustration 67  Instruments 319-020/31 Case 2 – Femoral Preparation 1 2 3 4 5 11 12 13 17 16 15 6 7 8 9 10 14 1 319-620/31 Instrument Tray 2, empty, 485 x 253 x 100 mm (incl. lid) 2 319-210/00 IM Alignment Instrument, femoral varus/valgus adjustment 3 319-211/01 Guide U-Bolt 4 319-215/00 Cutting Block, distal femur cut „S“ 5 319-220/00 Cutting Block, distal femur cut „L“ Cutting Blocks, 4-in-1-Femur Cutting Block 6 319-202/01 for size 1 7 319-202/16 for size 1B 8 319-202/02 for size 2 9 319-202/25 for size 2A 10 319-202/26 for size 2B 11 319-202/03 for size 3 12 319-202/04 for size 4 13 319-202/05 for size 5 14 319-505/00B* Step Drill 15 319-510/00 Guide Rod, intramedullary 16 319-200/02 Femoral Sizing/Rotation Alignment Instrument, femoral sizing and rotation adjustment 17 317-845/00 Femoral Sizer * with B = Hudson-Fitting 68 Instruments 319-030/31 Case 3 – Spacer 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1 319-630/31 Instrument Tray 3, empty, 485 x 253 x 100 mm (incl. lid) Shims 2 319-330/12 12 mm 3 319-330/14 14 mm 4 319-330/16 16 mm 5 319-330/18 18 mm 6 319-300/00 T-Handle 7 319-335/01 Correction Spacer, universal, white Spacers for flexion gap 8 319-322/01 Size 1, yellow 9 319-322/16 Sizen 1B, grey 10 319-322/02 Size 2+2A, green 11 319-322/26 Size 2B, red 12 319-322/03 Size 3, blue 13 319-322/04 Size 4, black 14 319-322/05 Size 5, brown Spacers for extension gap 15 319-310/01 Size „S“, white 16 319-315/01 Size „L“, white 69  Instruments 319-040/31 Case 4 – Tibia Preparation 1 2 3 4 5 6 7 8 10 9 11 12 17 16 15 14 13 22 21 20 19 18 23 24 25 26 27 28 29 30 34 33 32 31 1 319-640/31 Instrument Tray 4, empty, 485 x 253 x 100 mm (incl. lid) Trial Plateaus 2 319-415/01 Size 1 3 319-415/16 Size 1B 4 319-415/02 Size 2 5 319-415/25 Size 2A/2B 6 319-415/03 Size 3 7 319-415/04 Size 4 8 319-415/05 Size 5 9 319-430/01 Guide Sleeve 10 319-401/00 Locking Clip 11 319-570/00 Insertion Forceps 12 319-425/00 Tibial Blade Chisel Tibial Preparation Plates, right/left 13 319-400/01 Size 1 14 319-400/02 Size 2 15 319-400/03 Size 3 16 319-400/04 Size 4 17 319-400/05 Size 5 Shims 18 319-407/10 10 mm 19 319-407/12 12 mm 20 319-407/14 14 mm 21 319-407/16 16 mm 22 319-407/18 18 mm Trial Plateaus – Fixed Bearing 23 319-410/01 Size 1 24 319-410/16 Size 1B 25 319-410/02 Size 2 26 319-410/25 Size 2A/2B 27 319-410/03 Size 3 28 319-410/04 Size 4 29 319-410/05 Size 5 30 319-450/00 Impactor Handle for Tibial Component 31 319-437/03B* Tapered Reamer (Taper Cap) 32 319-437/05B* Tapered Reamer (L 50 mm) 33 319-437/08B* Tapered Reamer (L 80 mm) 34 319-437/12B* Tapered Reamer (L 120 mm) * with B = Hudson-Fitting 70 Instruments 445-008/00 Case 5 – Femoral Trial Prostheses 1 2 3 4 5 6 7 8 9 10 11 12 19 18 17 16 15 14 13 1 445-080/00 Instrument Tray 8, empty, 485 x 253 x 100 mm (incl. lid) 2 317-668/25 Femoral Trial, left, size 2A 3 317-668/01 Femoral Trial, left, size 1 4 317-668/26 Femoral Trial, left, size 2B 5 317-668/16 Femoral Trial, left, size 1B 6 317-668/03 Femoral Trial, left, size 3 7 317-668/02 Femoral Trial, left, size 2 8 317-667/03 Femoral Trial, right, size 3 9 317-667/05 Femoral Trial, right, size 5 10 317-667/26 Femoral Trial, right, size 2B 11 317-667/04 Femoral Trial, right, size 4 12 317-667/25 Femoral Trial, right, size 2A 13 317-667/01 Femoral Trial, right, size 1 14 445-205/00 Drill Template, Ø 5.5 mm 15 317-667/16 Femoral Trial, right, size 1B 16 317-667/02 Femoral Trial, right, size 2 17 317-668/05 Femoral Trial, left, size 5 18 317-668/04 Femoral Trial, left, size 4 19 445-210/00 Femoral Inserter/Extractor 71  Instruments 319-060/32 Case 6 – Femoral PS Preparation 1 12 – 15 20 – 23 24+25 26 27 28 2–8 9 – 11 16 – 19 34 31 32 29 33 30 1 319-660/32 Instrument Tray 6, empty, 485 x 253 x 100 mm (incl. lid) Trial Plateaus – Fixed Bearing PS 2 319-420/01 Size 1 3 319-420/16 Size 1B 4 319-420/02 Size 2 5 319-420/25 Size 2A/2B 6 319-420/03 Size 3 7 319-420/04 Size 4 8 319-420/05 Size 5 Femoral Trial Boxes 9 317-717/01B* Size 1 10 317-717/16B* Size1B 11 317-717/02B* Size 2 12 317-717/25B* Size 2A/2B 13 317-717/03B* Size 3 14 317-717/04B* Size 4 15 317-717/05B* Size 5 Femur-Probekästen 16 317-669/01 Size 1 17 317-669/16 Size 1B 18 317-669/02 Size 2 19 317-669/25 Size 2A 20 317-669/26 Size 2B 21 317-669/03 Size 3 22 317-669/04 Size 4 23 317-669/05 Size 5 24 317-668 Fixation Screws (4 pieces) 25 319-601/30 Sterilizing Box with base, silicon base and lid Box Guides 26 317-618/01 Size 1 27 317-618/16 Size 1B 28 317-618/02 Size 2 29 317-618/25 Size 2A 30 317-618/26 Size 2B 31 317-618/03 Size 3 32 317-618/04 Size 4 33 317-618/05 Size 5 34 319-535/00 Screwdriver, hex 2.5 mm * with B = Hudson-Fitting 72 Instruments 319-070/31 Case 7 – General Instruments 1 2 4 5 6 7 8 9 3 20 19 13–18 12 11 10 1 319-670/31 Instrument Tray 7, empty, 485 x 253 x 100 mm (incl. lid) 2 317-802/10 Impactor for Tibial Component, incl. PE Plateau, Gr. 1, 1B, 2 3 317-802/11 Impactor for Tibial Component, incl. PE Plateau, Gr. 2A, 2B, 3, 4 4 317-802/12 Impactor for Tibial Component, incl. PE Plateau, Gr. 5 5 317-802/53 Cutting Template 6 319-540/00 Screwdriver, hex. 2.0 mm 7 317-586 Inserter/Extraction Forceps for Wire Pins 8 319-260/00 Rasp 9 319-530/01 Screwdriver 10 317-649/08B* Twist Drill, Ø 5.5 mm 11 16-3287/00B* Adapter, for LINK power tool snap lock coupling 12 319-602/30 Sterilizing Box with base, silicon mat and lid consisting of: 13 319-555/01 Head Pin, 4 pieces 14 319-566/00 Drill Pin, 85 mm, Ø 3.0/3.5 mm, with stop, 4 pieces 15 319-581/00 Drill Pin, 80 mm, Ø 3.0 mm, 4 pieces 16 319-582/00 Drill Pin, 110 mm, Ø 3.0 mm, 4 pieces 17 319-560/02 Thread Pin, 85 mm, Ø 3.0/3.5 mm, with stop, 4 pieces 18 319-212/00 Fixation Adapter, 2 pieces 19 319-500/00 T-Handle 20 317-646 Driver * with B = Hudson-Fitting 73  Instruments 319-080/31 Case 8 – Final-Spacer 1 2 4 6 8 9–12 3 5 7 1 319-680/31 Instrument Tray 8, empty, 485 x 253 x 100 mm (incl. lid) Final-Spacer 2 319-341/01 Size 1 3 319-341/16 Size 1B 4 319-341/02 Size 2 5 319-341/25 Size 2A/B 6 319-341/03 Size 3 7 319-341/04 Size 4 8 319-341/05 Size 5 Shim 9 319-330/12 12 mm 10 319-330/14 14 mm 11 319-330/16 16 mm 12 319-330/18 18 mm 74 Instruments 340-200/01 Patella Instrument Set 1 2 3 4 5 6 7 8 26 9-12 25 24 23 22 20 21 19 18 17 16 15 14 13 1 340-015/01 Instrument Tray, empty, 485 x 253 x 100 mm (incl. lid) 2 340-007 Patella Pusher Attachment 3 340-306B Patella Drill, Ø 6.3 mm, with Hudson fitting, for Patella Component 3-pegs 4 optional* Adapter for snap lock chuck, optional (see page 64) Patella Drill Guides for patella holding clamp, Patella Component 3-pegs 5 340-225 Size 25 for 318-401/25 6 340-228 Size 28 for 318-401/28 7 340-231 Size 31 for 318-401/31 8 340-234 Size 34 for 318-401/34 Patella Reaming Guides for patella holding clamp, Patella Component 3-pegs 9 340-025 Size 25 for 318-401/25 10 340-028 Size 28 for 318-401/28 11 340-031 Size 31 for 318-401/31 12 340-034 Size 34 for 318-401/34 Patella Reamers for patella reaming guides, Patella Component 3-pegs, with Hudson fitting 13 340-134B Size 34 for 318-401/34 14 340-131B Size 31 for 318-401/31 15 340-128B Size 28 for 318-401/28 16 340-125B Size 25 for 318-401/25 Patella Trial Prostheses for Patella Component 3-pegs 17 340-334 Size 34 for 318-401/34 18 340-331 Size 31 for 318-401/31 19 340-328 Size 28 for 318-401/28 20 340-325 Size 25 for 318-401/25 21 340-006 Patella Resection Clamp 22 340-009 Patella Pusher Inserter 23 65-2000 Townley Femur Caliper 24 340-010 Patella Sizing Template 25 15-2042 Inserting Forceps for inserting the manipulating bearings, 215 mm 26 340-005 Patella Holding Clamp * Adapter optional: 16-3283/00, 16-3284/00, 16-3285/00 75  Instruments 319-010/31 Precision Tibia Resection Alignment 1 2 3 4 5 15 17 7 6 10 9 8 12 11 14 13 16* 1 319-610/31 Instrument Tray 1, empty, 485 x 253 x 100 mm (incl. lid) 2 319-140/01 Tibial Base Guide 3 319-110/01 EM Alignment Rod 4 319-525/00 Alignment Rod, extramedullary (external thread) 5 319-520/01 Alignment Rod, extramedullary (female thread) 6 319-115/01 Fixation Jig, extramedullary 7 319-165/00 Fixation Jig, extramedullary 8 319-125/01 Stylus, Referencer Defect Compartment (2 mm) 9 319-130/01 Stylus, Referencer Intact Compartment (10 mm) 10 319-135/01 Stylus, Referencer Intact Compartment (12 mm) 11 319-145/01 Cutting Block (symmetrical), right and left 12 319-150/01 Cutting Block (asymmetrical), right 13 319-155/01 Cutting Block (asymmetrical), left 14 319-120/01 Guide 15 319-160/00 Foot Clamp, intramedullary, silicon belt connection 16 317-538/01 Plastic Connector * 17 319-183/00 Foot Clamp, spring fixation * without illustration 76 Instruments 317-800/00 EXTRABONE Instrument Set 1 2 3 9 8 7 6 5 4 1 317-805/00 Instrument Tray, empty, 485 x 253 x 120 mm 2 317-840/00 Alignment Rod 3 317-815/00 Positioner Guide 4 317-825/00 Guide 5 317-820/00 Connector (3 parts) 6 317-810/00 Alignment Instrument 7 317-845/00 Femoral Sizer 8 317-835/00 Axis Alignment Guide 9 317-830/00 Positioner 77  Instruments Additional Instruments Hudson-Fitting (B) Standard tool connection. Adapter for power tool chuck Different adapters are available to ensure compatibility to allow various connections: Attachment 16-3283/01 Jacobs-Fitting (E) 16-3284/00 AO-Fitting (D) 16-3285/00 Harris-Fitting (C) A Sawblade, 317-588/01 without offset teeth, 1.24 mm thick Gauge for ligament tension Width (A) Width (A) 25 mm 13 mm Fitting 317-654/10 317-656/10 Synthes 317-654/11 317-656/11 Aesculap combi 317-654/12 317-656/12 3M 317-654/13 317-656/13 Zimmer/Hall combi 317-654/14 317-656/14 Stryker system 4 78 Accessories X-ray Templates 317-684/01 317-683/01 X-ray Templates for GEMINI SL, X-ray Templates for GEMINI SL – PS version, Set contains femoral and tibial implants Fixed Set contains femoral and tibial implants PS (Posterior Bearing, 110% actual size, 1 set of 7 sheets Stabilized), 110% actual size, 1 set of 7 sheets 317-658/00 X-ray Template GEMINI SL EXTRABONE, 110% actual size,1 sheet 79  Further Information PCL Protector GEMIN SL EXTRABONE Instrument for the protection of the posterior cruciate Extramedullary Femur Referencing ligament during resection of the tibia. LINK PorEx (TiNbN = Titan-Niobium-Nitrid) Patella Components Surface Modification for LINK implants for LINK Knee Prosthesis Systems For more information please register for our LINK Media Library (linkorthopaedics.com) 80 Important Information Please note the following regarding the use of our implants: 1. Choosing the right implant is very important. The size and shape of the human bone determines the size and shape of the implant and also limits the load capacity. Implants are not designed to withstand unlimited physical stress. Demands should not exceed normal functional loads. 2. Correct handling of the implant is very important. Under no circumstances should the shape of a finished implant be altered, as this shortens its life span. Our implants must not be combined with implants from other manufacturers. The instruments indicated in the Surgical Technique must be used to ensure safe implantation of the components. 3. Implants must not be reused. Implants are supplied sterile and are intended for single use only. Used implants must not be used again. 4. After-treatment is also very important. The patient must be informed of the limitations of the implant. The load capacity of an implant cannot compare with that of healthy bone! 5. Unless otherwise indicated, implants are supplied in sterile packaging. Note the following conditions for storage of packaged implants: • Avoid extreme or sudden changes in temperature. • Sterile implants in their original, intact protective packaging may be stored in permanent buildings up until the “Use by” date indicated on the packaging. • They must not be exposed to frost, dampness or direct sunlight, or mechanical damage. • Implants may be stored in their original packaging for up to 5 years after the date of manufacture. The “Use by” date is indicated on the product label. • Do not use an implant if the packaging is damaged. 6. Traceability is important. Please use the documentation stickers provided to ensure traceability. 7. Further information on the material composition is available on request from the manufacturer. Follow the instructions for use! Waldemar Link GmbH & Co. KG, Hamburg All content in this catalog, including text, pictures and data, is protected by law. Every instance of use, whether in part or in whole and which is not permitted by law, is subject to our prior consent. In particular, this applies to the reproduction, editing, translation, publishing, saving, processing, or passing on of content stored in databases or other electronic media and systems, in any manner or form. The information in the catalogs is solely intended to describe the products and does not constitute a guarantee. The Surgical Technique described has been written to the best of our knowledge and belief, but it does not relieve the surgeon of his/her responsibility to duly consider the particularities of each individual case. Products shown in this document may not be available in your country. The product availability is subject to the approval and/or registration regulations of the respective country. Please contact Waldemar Link GmbH & Co. KG if you have questions about the availability of LINK products in your country. Waldemar Link GmbH & Co. KG and/or other corporate affiliated entities own, use or have applied for the following trademarks in many jurisdictions: LINK, BiMobile, SP II, Modell Lubinus, E-Dur, EndoDur, T.O.P. II, BetaCup, CombiCup PF, CombiCup SC, CombiCup R, MobileLink, C.F.P., LCU, SP-CL, LCP, MIT-H, Endo-Model, Endo-Model SL, MP, MEGASYSTEM-C, GEMINI SL, SPAR-K, LCK, Link OptiStem, HX, TiCaP, X-LINKed, PorAg, LINK PorEx, BiPorEx, PorEx-Z, TrabecuLink, Tilastan, customLINK, RescueSleeve, Stactip, VACUCAST. Other trademarks and trade names may be used in this document to refer to either the entities claiming the marks and/or names or their products and are the property of their respective owners. © LINK • 737_GEMINI SL_OP.Impl.Instr_en_2021-03_001 Waldemar Link GmbH & Co. KG Barkhausenweg 10 · 22339 Hamburg · Germany Phone +49 40 53995-0 · [email protected] www.linkorthopaedics.com  REVISION KNEE SYSTEM Surgical Technique Explanation of Pictograms Manufacturer Article number Caution: Federal law restricts this device to sale by or on the order Material number Rx only of a physician. Contents CCK 02 Overview – Workflow of Surgical Steps: Surgical Technique: 04 Preoperative Planning 05 Approaches 06 Pins, Pin Instruments and Sawblades 08 Reamers 10 Trial Stems 12 Tibial Preparation: 12 Intramedullary Tibial Guide Assembly 13 Intramedullary Tibial Guide Alignment 16 Tibial Resection 17 Tibial Preparation 19 Tibial Augment Preparation 20 Tibial Male Taper Connection Preparation 21 Tibial Trial Component Assembly 24 Femoral Preparation: 24 Femoral Sizing: 25 Femoral Alignment Guide Assembly 26 Femoral Alignment Guide Positioning 28 Distal Femoral Resection 29 4-in-1 Femoral Cutting Block Assembly 31 4-in-1 Femoral Cutting Block Positioning 33 Femoral 4-in-1 Resection 34 Femoral Box Preparation 36 Femoral Male Taper Connection Preparation 37 Femoral Trial Assembly 40 Trial Reduction 42 Final Preparation 43 Extraction of Femoral Trial Component 44 Patella Preparation (Patella Resurfacing) 47 Final Implantation: 47 Augment Assembly, Modular Stem Assembly 50 Implantation 50 1 Fixed Bearing Modular Tibial Component Implantation 51 2 CCK Femoral Component Implantation 52 3 CCK PE Articulating Surface Implantation 54 4 Patella Implantation 54 Functional Test 55 Appendix 1, Implant Removal 58 Appendix 2, Extraction Stem Adapter and Trial Stems 59 Appendix 3, TrabecuLink Tibial Cones Compatibility Implants: 60 Implants Combination Overview 62 LinkSymphoKnee Femoral Components 64 LinkSymphoKnee Tibial Components 65 LinkSymphoKnee Articulating Surfaces 67 LinkSymphoKnee Press-Fit Stems 68 LinkSymphoKnee Cemented Stems, Centralizers 69 LinkSymphoKnee Cementless Stems 71 LinkSymphoKnee Replacement Sets for Cone Adapter 72 LinkSymphoKnee Femoral Augments 75 LinkSymphoKnee Tibial Augments 76 LinkSymphoKnee Patella Components Instruments: 77 LinkSymphoKnee Instrument Sets: Overview 101 Additional Instruments 102 Additional Information 103 Indications/Contraindications Important Information NOTE: To assist the reader of this Surgical Technique, the LinkSymphoKnee instruments used in the illustrated surgical steps are shown again at the bottom of each page (from 08 to 58). Take care to select the correct size of the instruments according to the individual surgical case. 01  Overview – Workflow of Surgical Steps CCK Preoperative Tibial Reaming, Tibial Preparation Planning IM Tibial Alignment and Resection (Approach) CCK Femoral Box Preparation Trial Reduction 02 Overview – Workflow of Surgical Steps Femoral Reaming and A/P Femoral Distal Femoral Resection Resection and Chamfer Cuts Final Tibial Preparation Final Implantation 03  Surgical Technique Preoperative Planning The anatomic landmarks in the knee joint are defined preoperatively by imaging the whole leg on the healthy and the affected side in the standing position. The angle between the anatomic axis (center of knee joint – intramedullary canal) and the mechanical axis (center of femoral head – center of knee joint – center of ankle to the second toe) determines the valgus angle (01). These angles should be determined for both knees. The valgus angle of a healthy knee joint is approximately 5°-7°. The appropriate implant size can be estimated preoperatively with X-ray templates. The necessary resections are determined by the size of the implant and the deformity corrections required. ATTENTION: The LinkSymphoKnee CCK has an inbuilt 6° valgus angle in the femoral stem. 01 01 04 Surgical Technique Approaches With the knee in slight flexion, a straight incision is made over the patella, as far as the tibial tuberosity (02). A medial parapatellar incision is made through the patellar retinaculum, capsule and synovial membrane (03). When making the parapatellar incision, the patella is pushed to one side to visualize the patellofemoral joint. Removal of the hypertrophic synovial membrane and parts of the fat pad allow access to the medial, lateral and intracondylar parts of the joint. Excess synovium should be removed in order to avoid postoperative im- pingement and adhesions. Some surgeons prefer total synovectomy. 02 03 Component Removal When removing the components to be revised, great care must be taken to preserve as much of the remaining bone stock as possible and to avoid the risk of fracture of the residual bone. Bone preservation can usually be achieved through the use of small flexible osteotomes, saws and high-speed burring instruments. 05  Surgical Technique Pins, Pin Instruments and Sawblades The LinkSymphoKnee Instruments are designed to be used with: Drill Pins Headed Drill Pins Bone Nails The Drill Pins, Headed Drill Pins and Bone Nails may be hammered in using the Universal Pin Inserter/ Extractor (A) or the Universal Pin Inserter (B). The Drill Pins, Headed Drill Pins and Bone Nails may be pulled out using the Universal Pin Inserter/Extractor (A), the Drill Pins and Headed Drill Pins are also designed to be drilled in and removed using the Power Driver (C) or the Power Driver with Snap Lock (D). The Bone Nail may be pulled out using the Universal Pin Inserter/Extractor (A) or the Slaphammer (E). B C D A1 E A Use the Universal Pin Inserter/Extractor (A) as shown in the picture (A1). OPTIONAL: ATTENTION: The Thread Pins* are designed The LinkSymphoKnee Instruments are to be drilled in and removed using the Power designed to be used also with Thread Pins*, Driver (C) or the Power Driver with Snap Lock headed or not headed. (D) only. * only available upon request The LinkSymphoKnee Instruments are designed for use with sawblades up to a max. thickness of 1.27 mm (page 101). 06 Surgical Technique Compatibility Drill Pins Headed Drill Bone Nails Thread Pins* Headed Thread Pins Pins* Universal Pin Inserter/Extractor Universal Pin Inserter Power Driver Power Driver with Snap Lock Slaphammer * only available upon request 07  Surgical Technique Reamers Cylindrical Reamers: The Cylindrical Reamers are available in diameters: 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22 mm. Different markings on the Reamers show the depths for different stems. ATTENTION: There are different markings for femur (F) and tibia (T). ATTENTION: The Cylindrical Reamers can be used only with the Cylindrical Cementless Stems, Cylindrical Press-Fit Stems and Conical Cemented Stems. Conical Reamers: The Conical Reamers are available in the following sizes: • L  ength: 128 mm, with diameter: 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 mm • L  ength: 158 mm, with diameter: 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 mm • L  ength: 188 mm, with diameter: 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 mm ATTENTION: The markings F and T show the depth of the stem on the Femoral side and Tibial side respectively. ATTENTION: The Conical Reamers can be used only with the Conical Cementless Stems. ATTENTION: When using the Cementless Modular Stems, ream with increasing diameters until the Reamer has achieved contact with the cortical bone over a continuous distance of approx. 50 mm. The Implant must correspond with the last Reamer used in terms of diameter and length. 08 Surgical Technique Ball Reamers: The Ball Reamers are available in the diameters: 10, 12, 14, 16, 18, 20, 22, 24, 26 mm ATTENTION: The Ball Reamers can be used only with the Conical Cemented Stems. ATTENTION: In the case of Conical Cemented Stems, the Reamer should be at least 2 mm larger than the planned stem diameter. 09  Surgical Technique Trial Stems Cylindrical Trial Stems, cementless: ATTENTION: Must be used for the cementless Cylindrical Stems and Cylindrical Press-Fit Stems only. Conical Trial Stems, cementless: ATTENTION: Must be used for the cementless Conical Stems only. Conical Trial Stems, cemented: ATTENTION: Must be used for the cemented Conical Stems only. 10 Surgical Technique When using Cemented Conical Stems, a Centralizer must be used. The Centralizers are available in diameter: 12, 14, 16, 18, 20, 22, 24 mm. Trial Centralizer Every Trial Stem has a hole for inserting a screwdriver (AF 2.5) to loosen the Trial Stem when the connection is too tight (04-05). Hole for the Screwdriver 04 05 ATTENTION: The Trial Stems for the 50 mm Cemented Conical Stems feature an in-built Trial Centralizer. 11  Surgical Technique Tibial Preparation Intramedullary Tibial Guide Assembly Assemble the appropriate Tibial Cutting Block to the CCK IM Tibial Guide and lock it by twisting the knob of the IM Tibial Guide clockwise until it clicks in the "lock position” (06). CCK IM Tibial Guide Tibial Cutting Block Tibial Cutting Guide Connector 06 LinkSymphoKnee CCK Instrument Set includes the following Tibial Cutting Blocks: left right Instruments 881-059/00 151-202/00 151-204/00 CCK IM Tibial Guide 3° Tibial Cutting Tibial Cutting Block, Guide Connector right 12 Surgical Technique Intramedullary Tibial Guide Alignment Open the tibial canal using the Step Drill (07). ATTENTION: In case of primary CCK, the entry point for opening the tibia can be marked with the electrocautery, for example. It is usually located at the point of attachment of the anterior cruciate ligament. Assemble the Reamer with the T-handle (08). Slowly introduce the Reamer into the canal to pre- vent building up pressure. Use the Reamer until it achieves a good stability in the tibial canal. Slide the CCK IM Tibial Guide assembly onto the Reamer (09). ATTENTION: After reaming, it is possible to use the Trial Stem Rod Intramedullary assembled to the previously selected Trial Stem. This trial construct 07 08 can be used, instead of the Reamer, as a guide for all other instruments (09a). Insert the construct into the bone until reaching the tibial marking (09b). The Trial Stem Rod Intramedullary must be used when it is planned to implant a stem shorter than or equal to 95 mm. 09 09a 09b Instruments 319-505-00B Step Drill 881-059/00 151-202/00 151-204/00 15-6053/00 881-056/00 881-069/16 151-716/16 CCK IM Tibial Tibial Cutting Tibial Cutting T-handle Trial Stem Rod Reamer, cementless Trial Stem, cementless, Guide 3° Guide Connector Block, right Intramedullary cylindrical, Ø 16 mm cylindrical, Ø 16 mm 13  Surgical Technique OPTIONAL: To assess tibial alignment, insert the Alignment Rod into the IM-Tibial Guide. Rotation and alignment may be checked by ensuring that the Alignment Rod remains parallel with the tibial axis (10). 10 Instruments 881-069/16 151-202/00 445-113/20 151-204/00 881-059/00 Reamer, cementless Tibial Cutting Alignment Rod, long Tibial Cutting Block, CCK IM Tibial Guide 3° cylindrical, Ø 16 mm Guide Connector right 14 Surgical Technique Insert the foot of the Adjustable Stylus into the slot of the Tibial Cutting Block and adjust it to the appropriate level (11). 11 The scale on the body of the Adjustable Stylus indicates the quantity of bone and residual cartilage to be resected. ATTENTION: LinkSymphoKnee CCK Total Knee System has a minimum tibial component thickness of 10 mm (Tibial baseplate + PE-articulating surface). Take care to restore the joint line. Set the Adjustable Stylus according to the patient's anatomy, to avoid excessive tibial resection. After the tibial resection level has been set, pin the Tibial Cutting Block through the anterior parallel "0" holes, using two Drill Pins (12). 12 Disconnect and remove the IM Tibial Guide and the reamer. The resection level may be adjusted by using the distal or proximal pin holes, which move the block 2 mm more proximal or 2 mm more distal. If desired, the Tibial Cutting Block can be fixed with an additional Headed Drill Pin placed through the distal angled hole. Confirm the tibial resection level using Cutting Template introduced as a free sawblade into the Tibial Cutting Block. Instruments 445-124/65 445-125/35 881-059/00 151-202/00 151-204/00 881-069/16 445-111/00 Drill Pin Headed Drill CCK IM Tibial Tibial Cutting Tibial Cutting Reamer, cementless Adjustable Stylus Pin Guide 3° Guide Connector Block, right cylindrical, Ø 16 mm 15  Surgical Technique Tibial Resection Resect the tibia using an oscillating saw and a sawblade max. 1.27 mm thick (13). 13 14 OPTIONAL: It is possible to add the Quick Connect Handle to the Tibial Cutting Block to check the rotation again (14). In case of bone loss, use the 5, 10 or 15 mm cutting slot to prepare the bone for Tibial Augments. ATTENTION: When using only an augment on one side (medial or lateral), use the slot in the middle to per- form the sagittal resection (15). 15 ATTENTION: When using an Offset Stem, prepare the bone for the Tibial Augment in a later stage of the surgical procedure, after setting the offset position and magnitude. Remove the Tibial Cutting Block and Pins. Instruments 151-204/00 445-124/65 445-125/35 445-112/00 445-113/10 Tibial Cutting Block, Drill Pin Headed Drill Handle, quick connect Alignment Rod, short right Pin 16 Surgical Technique Tibial Preparation Slowly reposition the Reamer into the tibial canal. Place the Tibial Preparation Plate CCK onto the tibia over the Reamer. Assess the tibial size to achieve maximal coverage of the resected surface (16). Slide the Offset Selector CCK (17) over the Reamer and assemble it to the Tibial Preparation Plate CCK (18). 16 Offset Selector CCK: Offset position indicator Hole for Reamer Offset magnitude options 0 mm, 3 mm, 6 mm Turn it clockwise to change the position of the offset. Press and push to change the 17 offset magnitude ATTENTION: There is only one way to assemble the Offset Selector onto the Tibial Preparation Plate CCK. 18 Instruments 881-099/00 881-285/60 881-069/16 Offset Selector CCK Tibial Preparation Plate CCK, Reamer, cementless Size 6 cylindrical, Ø 16 mm 17  Surgical Technique Set the appropriate offset magnitude and the position. Check the rotational alignment by inserting the alignment rod into the handle of the Tibial Preparation Plate CCK (19). Fix the Tibial Preparation Plate CCK with 2 Drill Pins (20). 19 20 Record the magnitude and the position of the offset from the Offset Selector CCK. Instruments 881-099/00 881-285/60 445-113/20 881-069/16 445-124/65 Offset Selector CCK Tibial Preparation Plate CCK, Alignment Rod, long Reamer, cementless Drill Pin Size 6 cylindrical, Ø 16 mm 18 Surgical Technique Tibial Augment Preparation In case of bone loss, Tibial Trial Augments are available corresponding to each final tibial augment size and side. For preparing the tibial bone, slide the Tibial Cutting Block with the CCK Tibial Cutting Guide Connector onto the CCK Tibial Preparation Plate. Remove the Reamer and CCK Offset Selector (21). Use the medial or lateral (or both) cutting slot at 5, 10 or 15 mm to resect the tibia for the selected augment (height 5, 10, 15 mm). 21 ATTENTION: When using only half augment (medial or lateral), use the slot in the middle to perform the sagittal resection (22). 22 23 Assemble the appropriate Trial Augment under Tibial Preparation Plate (23). Instruments 151-202/00 445-124/65 445-125/35 881-335/11 151-204/00 881-285/60 Tibial Cutting Drill Pin Headed Drill Tibial Trial Augment, Medial-Right/ Tibial Cutting Block, Tibial Preparation Plate CCK, Guide Connector Pin Lateral-Left, Size 5-6, H = 5mm right Size 6 19  Surgical Technique Tibial Male Taper Connection Preparation Attach the Tibial Reamer Guide CCK onto the Tibial Preparation Template (24). Use the Tapered Reamer CCK until it stops onto the Tibial Reamer Guide CCK (25). 24 25 ATTENTION: When using an Offset Stem, assemble the Offset Reamer Stopper to the Tapered Reamer CCK (26 & 27). 26 ATTENTION: This step of the surgical technique can only be skipped when using straight stems with a diameter bigger than 16 mm. 27 Instruments 881-285/60 881-065/09 881-065/00 881-067/17 445-124/65 Tibial Preparation Plate CCK, Reamer Stopper, offset Tibial Reamer Guide, CCK Tapered Reamer, CCK Drill Pin Size 6 20 Surgical Technique Tibial Trial Component Assembly In case of bone loss, add the previously selected Tibial Trial Augment to the Tibial Trial Component CCK (28). Fully assembled Tibial Trial Augment 1 1 Neutral, 3 mm or 6 mm Offset Adapter 2 2 28 Trial Stem assembly sequence: Tibial Trial Component CCK + (1) Adapter + (2) Trial Stem (28) ATTENTION: When using an Offset Stem, select the 3 mm or the 6 mm Offset Adapter according to the offset magnitude previously selected. For the correct offset position refer to the setting on the CCK Offset Selector (29). 29 Instruments 881-099/00 881-258/60 151-806/06 151-501/00 151-716/16 881-335/11 Offset Selector CCK Tibial Trial Component, 6 mm Offset Adapter Neutral Stem Adapter Trial Stem, cementless, Tibial Trial Augment, Medial-Right/ CCK, Size 6 cylindrical, Ø 16 mm Lateral-Left, Size 5-6, H = 5mm 21  Surgical Technique The Offset Adapters for the 3 mm and 6 mm offset feature the same markings as on the CCK Offset Selector (30 & 31). Marking on the Offset Adapter for the offset position. Marking on the CCK Offset Selector for the offset position. 30 31 On the ventral/anterior side of the CCK Tibial Trial Component there is a marking that shows the correct reference position for the Trial Offset Adapter (30 & 31a). 31a Instruments 881-099/00 151-806/06 881-258/60 Offset Selector CCK 6 mm Offset Adapter Tibial Trial Component, CCK, Size 6 22 Surgical Technique Once the Trial Stem is assembled, the entire construct is locked and the offset position will not change. ATTENTION: The length of the assembly (Trial Stem Adapter + Trial Stem) is equal to the length of the final stem implant (32). ATTENTION: In case of Cemented Stems, assemble a Trial Centralizer (33) to the Trial Stem. Open the handle of the Tibial Inserter and attach it to the Tibial Trial Component. Use the Tibial Inserter to slowly introduce the Tibial Trial Component into the tibial bone (34). 32 33 34 It is possible to secure the rotation of the Tibial Trial Component using two Bone Nails (L = 25 mm or L = 35 mm) (35). 35 Instruments 881-258/60 445-128/35 151-806/06 151-106/16 881-042/00 151-716/16 Tibial Trial Component, Bone Nail 6 mm Offset Adapter Trial Centralizer, 16 mm Tibial Inserter Trial Stem, cementless, CCK, Size 6 cylindrical, Ø 16 mm 23  Surgical Technique Femoral Preparation For femoral preparation, the knee is flexed to 90°. The entry point for opening the femur can be marked with the electrocautery, for example. It is usually located approx. 3-5 mm medially above the intercondylar fossa. The medullary canal is opened with the Step Drill (36). 36 Femoral Sizing The CCK Femoral Sizer Template may be placed over the femur to assess the A/P and M/L size and position (37). 37 Use the Reamer until it achieves a good stability into the femoral canal. Slowly introduce it into the canal to prevent building up pressure. Slide the handle of the CCK Femoral Sizer Template over the reamer and assess the M/L femoral size (38). The vertical markings on the template handle represent the M/L width of the femoral component. 38 38a 38b ATTENTION: After reaming, it is possible to use the Trial Stem Rod Intramedullary assembled to the previously selected Trial Stem. This trial construct can be used, instead of the Reamer, as a guide for all other instruments (38a). Insert the construct into the bone until reaching the femoral marking (38b). The Trial Stem Rod Intramedullary must be used when it is planned to implant stems lengths shorter than or equal to 95 mm. Instruments 881-069/16 881-056/00 151-716/16 881-105/60 Reamer, cementless Trial Stem Rod Trial Stem, cementless, Femoral Sizer Template CCK, cylindrical, Ø 16 mm Intramedullary cylindrical, Ø 16 mm Size 6 24 Surgical Technique Femoral Alignment Guide Assembly In order to lock the CCK Distal Femoral Cutting Block (39), twist the knob of the Femoral Alignment Guide, Varus/Valgus Adjustment 6° clockwise until it clicks in the "lock position” (40). CCK Femoral Distal Cutting Block The first cutting slot allows for a clean up cut of 2 mm. 39 ATTENTION: Ensure that the correct Femoral Alignment Guide, Varus/Valgus Adjustment 6° has been selected. The "Right" one or the "Left" one is selected according to the operated leg. 40 Instruments 881-159/00 881-050/06 Femoral Cutting Block, CCK, Femoral Alignment Guide, Distal Cut Varus/Valgus Adjustment 6°, right 25  Surgical Technique Femoral Alignment Guide Positioning Slide the CCK Femoral Alignment Guide over the Reamer. ATTENTION: To slide the Alignment Guide onto the Reamer, press the spring on the side of the CCK Femoral Alignment Guide (41). ATTENTION: Joint line/patella height corrections noted preoperatively should be assessed for any proximal/distal (augment/resection) adjust- ments. 41 Note any augment variations for use on the femoral CCK 4-in-1 Cutting Block and Femoral Trial (42). OPTIONAL: To confirm the valgus angle, attach the Quick Connect Handle to the Distal Cutting Block and then insert the Alignment Rod into the Quick Connect Handle. Extend the Alignment Rod assembly to the center of the femoral head (43). 42 43 Instruments Alignment Rods: 445-113/10 short, 445-113/20 long 881-069/16 317-802/53 881-050/06 881-159/00 Reamer, cementless Cutting Template Femoral Alignment Guide, CCK, 445-112/00 Femoral Cutting Block, CCK, cylindrical, Ø 16 mm Varus/Valgus Adjustment 6°, right Handle, quick connect Distal Cut 26 Surgical Technique The rotation can be checked with markings for the Whiteside line and the epicondylar line (44). 44 For a stable resection of the distal cut, the Reamer and the CCK Femoral Alignment Guide may be left in situ. To secure the CCK Distal Femoral Cutting Block to the femur, two Drill Pins are inserted into the "0" pin holes (45). OPTIONAL: To fully secure the CCK Femoral Cutting Block to the femur, two Headed Drill Pins are inserted into oblique holes. 45 Instruments 881-069/16 881-159/00 881-050/06 445-124/65 445-125/35 Reamer, cementless Femoral Cutting Block, CCK, Femoral Alignment Guide, CCK, Drill Pin Headed Drill cylindrical, Ø 16 mm Distal Cut Varus/Valgus Adjustment 6°, right Pin 27  Surgical Technique Distal Femoral Resection The Cutting Template can be used to check the level of the distal resection. Use an oscillating saw (max. 1.27 mm thick) through the cut slot to resect the distal femur (46). 46 Remove the Pins, the Cutting Block and the CCK Femoral Alignment Guide, leaving the Reamer in situ. If it is necessary to re-cut the distal femur, reposition the CCK Femoral Cutting Block onto the +2 or +4 holes for a +2 mm re-cut or a +4 mm re-cut respectively. Instruments 881-069/16 881-159/00 881-050/06 445-124/65 445-125/35 317-802/53 Reamer, cementless Femoral Cutting Block, CCK, Femoral Alignment Guide, CCK, Drill Pin Headed Drill Cutting Template cylindrical, Ø 16 mm Distal Cut Varus/Valgus Adjustment 6°, right Pin 28 Surgical Technique 4-in-1 Femoral Cutting Block Assembly Select the CCK 4-in-1 Femoral Cutting Block that matches the femur A/P size previously determined (47). 47 48 ATTENTION: The LinkSymphoKnee Instrument Set features eleven CCK 4-in-1 Femoral Cutting Blocks, one for each A/P femoral size. LinkSymphoKnee CCK 4-in-1 Femoral Cutting Block mimics precisely the M/L size of the standard final femoral components (0 - 10). The M/L size of the wide femoral components (3+, 4+, 5+) can be assessed later in the surgical technique. ATTENTION: Joint line/patella height corrections noted preoperatively and at the Distal femoral resection step should be accounted for in the Femoral Trial Augments selection. Attach the appropriate Femoral Trial Augment to the posterior face of the CCK 4-in-1 Femoral Cutting Block (48). ATTENTION: In order to build a 15 mm Femoral Trial Augment, combine a 10 mm + a 5 mm Femoral Trial Augment. Now assemble the CCK Offset Selector (49) onto the CCK 4-in-1 Cutting Block. Offset position indicator Hole for Reamer Offset magnitude options 0 mm, 3 mm, 6 mm Turn it clockwise to change the position of the offset. Press and push to change the 49 offset magnitude Instruments 881-099/00 881-115/60 881-302/91 Offset Selector CCK Femoral Cutting Block, CCK, Femoral Augment Trial, 5 mm 4-in-1 Cut, Size 6 29  Surgical Technique ATTENTION: The CCK Offset Selector can be used either for the left or the right leg. Ensure that the CCK Offset Selector is assembled correctly according to the operated leg (50). Slide the CCK 4-in-1 Cutting Block construct onto the Reamer (51). 50 51 Instruments 881-099/00 881-302/91 881-115/60 881-069/16 Offset Selector CCK Femoral Augment Trial, 5 mm Femoral Cutting Block, CCK, Reamer, cementless 4-in-1 Cut, Size 6 cylindrical, Ø 16 mm 30 Surgical Technique 4-in-1 Femoral Cutting Block Positioning Assess the A/P and M/L position ensuring the rotation of the CCK 4-in-1 Cutting Block is aligned with the epicondylar axis. OPTIONAL: Insert the Cutting Template through the lateral side of the anterior slot of the CCK 4-in-1 Femoral Cutting Block to verify the correct anterior resection before cutting the femur and to ensure that notching is unlikely to occur (52). 52 If there is risk of unacceptable notching, it is possible to adjust the offset magnitude or offset position for prevention. OPTIONAL: The flexion gap may be checked by using the Flexion Spacer for the 4-in-1 Cut in combination with the CCK 4-in-1 Femoral Cutting Block. The Flexion Spacer is placed between the CCK 4-in-1 Femoral Cutting Block (with its stepped side pushed as far as possible under the unresected femoral condyles) and the resected tibia (53). If needed Shims can be used. 53 ATTENTION: Use the Flexion Spacer for Micro-Sizes with femoral sizes 0, 1 and 2. Instruments 881-069/16 881-115/60 881-011/02 881-099/00 317-802/53 Reamer, cementless Femoral Cutting Block, CCK, Flexion Spacer 4-in-1 Cut Offset Selector CCK Cutting Template cylindrical, Ø 16 mm 4-in-1 Cut, Size 6 31  Surgical Technique OPTIONAL: Use the CCK Flexion Spacer for the 4-in-1 Cut to check the flexion gap between the CCK 4-in-1 Femoral Cutting Block and the top surface of the Tibial Trial Component CCK (54). 54 ATTENTION: All Flexion Spacers are used only to assess the flexion gap. ATTENTION: All Flexion Spacers are designed to assess the flexion gap in combination with the CCK 4-in-1 Femoral Cutting Block. The Flexion Spacer can be connected to a 4 mm or 8 mm Shim to allow evaluation of multiple thicknesses (55a & 55b): 10 mm + 4 mm shim = 14 mm 12 mm + 4 mm shim = 16 mm 10 mm + 8 mm shim = 18 mm 12 mm + 8 mm shim = 20 mm 10 mm + 4 mm shim + 8 mm shim = 22 mm 12 mm + 4 mm shim + 8 mm shim = 24 mm 55a 55b Record the magnitude and the position of the offset. Instruments 881-069/16 881-115/60 881-011/02 881-099/00 881-258/60 881-013/00 881-019/04 Reamer, cementless Femoral Cutting Block, Flexion Spacer Offset Selector Tibial Trial Component, Flexion Spacer CCK Shim, Spacer, cylindrical, Ø 16 mm CCK, 4-in-1 Cut, Size 6 4-in-1 Cut CCK CCK, Size 6 4-in-1 Cut, H = 10-12 mm H = 4 mm 32 Surgical Technique Femoral 4-in-1 Resection After final placement of the CCK 4-in-1 Femoral Cutting Block, insert two Headed Drill Pins into the oblique pin holes on the medial and lateral aspects of the Cutting Block. NOTE: when the CCK 4-in-1 Femoral Cutting Block is assembled to a Femoral Augment Trial construct of 15 mm, use the oblique pins located at the opposite side respect to the Femoral Augment Trial. Protecting the collateral ligaments, use a max. 1.27 mm thick oscillating sawblade to complete anterior, posterior, posterior chamfer and anterior chamfer resections as well as any 5 mm and 10 mm posterior augment resections (56). 56 ATTENTION: Use a narrow sawblade with sizes 0, 1 and 2. Instruments 881-069/16 881-115/60 881-099/00 445-125/35 Reamer, cementless Femoral Cutting Block, Offset Selector CCK Headed Drill cylindrical, Ø 16 mm CCK, 4-in-1 Cut, Size 6 Pin 33  Surgical Technique Femoral Box Preparation Select the appropriate size of the CCK Box Guide that matches the femur A/P size previously determined. ATTENTION: The CCK Box Guide is symmetrically designed to permit universal use. The LinkSymphoKnee CCK instruments feature 5 CCK Box Guides (0-1-2, 3-4, 5-6, 7-8 and 9-10) Assemble the CCK Box Guide to the anterior surface of the CCK 4-in-1 Cutting Block (57). 57 Instruments 445-125/35 881-115/60 881-302/91 881-069/16 881-099/00 881-114/56 Headed Drill Femoral Cutting Block, CCK, Femoral Augment Trial, Reamer, cementless Offset Selector Femoral Box Guide, CCK, Pin 4-in-1 Cut, Size 6 5 mm cylindrical, Ø 16 mm CCK Size 5-6 34 Surgical Technique Fix the CCK Box Guide to the bone with two Drill Pins, remove the CCK 4-in-1 Cutting Block, the Reamer and the Offset Selector (58). OPTIONAL OR 58 59 OPTIONAL: The primary PS Box Guide may also be used for the CCK box preparation. The appropriate size of the primary PS Box Guide can be positioned onto the 2 parallel pins of the CCK Box Guide onto the anterior femur (59). Using a narrow sawblade, resect for the M/L walls and the distal wall of the femoral box through the CCK Box Guide (Anterior/Posterior) (59a). Slot for the CCK box preparation. 59a 60 ATTENTION: When completing the notch cut, be careful to avoid excessive angulation of the sawblade or penetration past the posterior femoral cortex to avoid injury to the neurovascular structures. Avoid undercutting the condyles. ATTENTION: When using the primary PS Box Guide, use the CCK cutting slot to resect the distal wall of the femoral box (60). ATTENTION: When using the primary PS Box Guide, attach the Femoral Trial Augment to increase the stability of the construct in case of bone loss (60a & 60b). 60a 60b Instruments 445-124/65 881-302/91 881-114/56 881-113/60 Drill Pin Femoral Augment Trial, Femoral Box Guide, CCK, Femoral PS Box Guide, 5 mm Size 5-6 Size 6 35  Surgical Technique Femoral Male Taper Connection Preparation Attach the CCK Femoral Box Reamer Guide onto the CCK Box Guide (61) or to the primary PS Box Guide (61b). 61 61b ATTENTION: The CCK Femoral Box Reamer can be used for a LEFT and for a RIGHT knee. Take care to assemble it properly according to the operated leg (61 & 61b). Use the Tapered Reamer CCK until it stops onto the CCK Femoral Box Reamer Guide (62). 62 ATTENTION: When using an Offset Stem, assemble the Offset Reamer Stopper to the Tapered Reamer CCK (63 & 64). 63 64 ATTENTION: This step of the surgical technique can only be skipped when using non-offset stems with diameter bigger than 16 mm. Instruments 881-113/60 881-114/56 881-067/17 881-116/00 445-124/65 881-065/09 Femoral PS Box Guide, Femoral Box Guide, Tapered Reamer, CCK Reamer Guide, Drill Pin Reamer Stopper, offset Size 6 CCK, Size 5-6 Femoral box, CCK 36 Surgical Technique Femoral Trial Assembly The LinkSymphoKnee CCK Instrument Set features a specific femoral trial component for each CCK femoral size. In case of bone loss, add the previously selected Femoral Trial Augments to the CCK Femoral Trial Component (65). (2) Neutral, (1) 3 mm or 6 mm Offset Adapter 65 Trial Stem assembly sequence: CCK Femoral Trial Component + (1) Adapter + (2) Trial Stem (65). ATTENTION: When using an Offset Stem select the 3 mm or the 6 mm Offset Adapter according to the offset magnitude previously selected. For the correct position refer to the setting on the CCK Offset Selector (66). 66 Instruments 881-099/00 151-806/06 151-501/00 151-716/16 881-150/60 881-302/91 Offset Selector 6 mm Offset Adapter Neutral Stem Adapter Trial Stem, cementless, Femoral Trial CCK, Femoral Augment Trial, CCK cylindrical, Ø 16 mm right, size 6 5 mm 37  Surgical Technique The Trial Offset Adapters for the 3 mm and 6 mm offset have the same markings as the CCK Offset Selector (67). Marking on the Offset Adapter for the offset position. Marking on the CCK Offset Selector for the offset position. 67 On the lateral side of the box of the CCK Femoral Trial Component there is a marking that shows the correct reference position for the Trial Offset Adapter (68). 68 Instruments 881-150/60 151-806/06 881-099/00 Femoral Trial CCK, 6 mm Offset Adapter Offset Selector right, size 6 CCK 38 Surgical Technique Once the Trial Stem is assembled, the entire construct is locked and the offset position will not change. ATTENTION: The length of the assembly (Trial Stem Adapter + Trial Stem) is equal to the length of the final stem (69). ATTENTION: In case of Cemented Stems, assemble a Trial Centralizer (70) to the Trial Stem. 69 70 Use the Femoral Inserter/Extractor to slowly introduce the CCK Femoral Trial Component into the femoral bone (71). 71 OPTIONAL: It is feasible to resect the bone for femoral augments using an oscillating sawblade through the CCK Femoral Trial Component (73). Release the Femoral Inserter/Extractor and use the Femoral Impactor Tip (assembled to the Impactor/ Extractor Handle) to complete the trial component impaction (72). 72 73 It is possible to secure the position of the Trial Femoral Component using pins. Instruments 151-106/16 151-806/06 881-041/00 151-716/16 881-150/60 445-207/00 881-041/99 Trial Centralizer, 6 mm Offset Adapter Femoral Trial Stem, cementless, Femoral Trial CCK, Impactor/Extractor Femoral Impactor Tip 16 mm Inserter/Extractor cylindrical, Ø 16 mm right, size 6 Handle 39  Surgical Technique Trial Reduction Perform a trial reduction with all trial components – CCK Femoral Trial Component, Tibial Trial Component CCK and CCK Trial Plateau (73). 74a 74 Select the appropriate size of the CCK Trial Plateau. The following table shows the possible size combinations: CCK Femoral Component 0 1 2 3/3+ 4/4+ 5/5+ 6 7 8 9 10 1 CCK Articulating x x x x x x CCK Articulating Surface 1-2 2 Surface 1-2up x x x x x x Tibial Component 3 x CCK Articulating x x x x CCK Articulating Surface 3-4 4 x Surface 3-4down x x x x 5 x x x x x CCK Articulating Surface 5-6 6 x x x x x 7 x x x x x CCK Articulating Surface 7-8 8 x x x x x 9 x x x x x x x CCK Articulating Surface 9-10 10 x x x x x x x Symbol Description: x = Combination not permitted Select the appropriate thickness of the CCK Trial Plateau: 10 mm, 12 mm, 14 mm or 16 mm. ATTENTION: For adjusting the height of the Trial Plateau beyond 16 mm, use the +4 mm Shim or the +8 mm Shim (74) in the following combinations: 14 mm Trial Plateau + 4 mm Shim = 18 mm 12 mm Trial Plateau + 8 mm Shim = 20 mm 14 mm Trial Plateau + 8 mm Shim = 22 mm 16 mm Trial Plateau + 8 mm Shim = 24 mm Instruments 881-250/85 151-716/16 881-258/60 881-255/10 881-150/60 151-806/06 Shim Trial Plateau, CCK Trial Stem, cementless, Tibial Trial Component, Trial Plateau CCK, Femoral Trial CCK, 6 mm Offset Adapter H = +8 mm, size 5-6 cylindrical, Ø 16 mm CCK, Size 6 Size 5-6, H = 10 mm right, size 6 40 Surgical Technique ATTENTION: Always use a stem with the Femoral and with the Tibial Component when implanting a LinkSymphoKnee CCK Articulating Surface. ATTENTION: For more implant options please refer to the LinkSymphoKnee CR-PS-PS+ Surgical Technique. OPTIONAL: It is possible to fix the CCK Trial Plateau to the CCK Tibial Trial Component using a Trial Plateau Locking Screw. Select the Short Tibial Plateau Locking Screw when using a CCK Trial Plateau without Shim or with the +4 mm Shim (75), whereas use the Long Trial Plateau Locking Screw when using a CCK Trial Plateau with +8 mm Shim (76). Use the Torque Wrench (hex 2.5 mm) to lock the Trial Plateau Locking Screw in place (77). 75 76 77 Instruments 15-2545 Torque Wrench, hex 2.5 mm Locking Screws Tibial Plateau: 881-052/00 Short, 881-053/00 Long 881-250/85 151-716/16 881-258/60 881-255/10 Shim Trial Plateau, CCK Trial Stem, cementless, Tibial Trial Component, Trial Plateau CCK, 151-806/06 H = +8 mm, size 5-6 cylindrical, Ø 16 mm CCK, Size 6 Size 5-6, H = 10 mm 6 mm Offset Adapter 41  Surgical Technique Final Preparation Attach the size-specific CCK Tibial Keel Punch to the Impactor/Extractor Handle. Choose the appropriate CCK Tibial Keel Punch according to the size of the CCK Tibial Trial Component. ATTENTION: The LinkSymphoKnee Instrument Set features five CCK Tibial Keel Punches, each for two tibial sizes: 1-2, 3-4, 5-6, 7-8 and 9-10. After confirming the rotation of the CCK Tibial Trial Component, carefully impact the CCK Tibial Keel Punch until it is fully seated onto the CCK Tibial Trial Component (78). Align Impact Unlock Remove 78 OPTIONAL: It is possible to perform a final trial reduction (79). Make sure that no bony structures (e.g. osteophytes) or local soft tissue interfere with the range of motion. Remove the Tibial Trial Component assembly. 79 Instruments 445-207/00 881-258/60 881-255/10 881-275/56 151-806/06 151-716/16 881-150/60 Impactor/Extractor Tibial Trial Component, Trial Plateau CCK, Tibial Keel Punch CCK 6 mm Offset Adapter Trial Stem, cementless, Femoral Trial CCK, Handle CCK, Size 6 Size 5-6, H = 10 mm Size 5-6 cylindrical, Ø 16 mm right, size 6 42 Surgical Technique Extraction of Femoral Trial Component OPTIONAL: In order to extract the Femoral Trial Components, it is possible to use the Slaphammer in combination with the Femoral Inserter/Extractor (80). 80 Assemble the Femoral Inserter/Extractor on the CCK Femoral Trial Component (81). 81 Use the Slaphammer to remove the Femoral Trial assembly (82). 82 Instruments 445-206/00 881-041/00 881-150/60 151-806/06 151-716/16 Slaphammer Femoral Femoral Trial CCK, right, 6 mm Offset Adapter Trial Stem, cementless, Inserter/Extractor size 6 cylindrical, Ø 16 mm 43  Surgical Technique Patella Preparation (Patella Resurfacing) The following instructions describe how to use the LinkSymphoKnee Patella Component and they assume the use of the instrument set available for this procedure. Sizing A Patella Sizing Template corresponding to the implants is available (83). The size of implant is determined by placing the Sizing Template slightly medial and superior on the patella surface (84). 83 84 ATTENTION: The LinkSymphoKnee system includes 6 sizes of Patella Components. Each size features a different implant thickness and diameter. In the table below, all Patella Component dimensions are shown. LinkSymphoKnee Patella Components – 3-peg cemented H Ø Ø Height (H) UHMWPE E-Dur * mm mm 880-501/25 880-511/25 25 6 880-501/28 880-511/28 28 6 880-501/31 880-511/31 31 7 880-501/34 880-511/34 34 8 880-501/37 880-511/37 37 9 880-501/40 880-511/40 40 10 * E-Dur = Highly crosslinked UHMWPE (X-Linked PE) with Vit-E Instruments 881-509/00 Patella Sizing Template 44 Surgical Technique Patella Resection Insert the Resection Guide (A) into the second groove A from the top of the Patella Clamp Handle (B) (85). Now, insert the Depth Gauge (C) into the first groove from the top of the Patella Clamp Handle (B) (86). B C 85 86 Set the appropriate resection level corresponding to the size of the patella component previously determined (87). 87 Position the Patella Clamp so that the sectional plane lies parallel to the extended patellar tendon. The Depth Gauge must lie on the bone. While pressing the hand grips, the Patella Clamp firmly fixes the patella by means of the integrated ratchet (88). If necessary, release the ratchet by pressing the trigger on the Patella Clamp Handle. 88 89 ATTENTION: It is important to ensure that the remaining patella is sufficiently thick (min. 12 mm). The resection is carried out using an oscillating saw with a max.1.27 mm thick sawblade. The saw is guided using the saw slots of the Resection Guide (89). Instruments 445-902/00 445-903/00 881-500/00 Patella Clamp, Patella Clamp, Patella Clamp, Handle Resection Guide Depth Gauge 45  Surgical Technique Drilling the Anchoring Holes Insert the Drill Guide (E) for the anchoring holes into the first slot from the top of the Patella Clamp Handle (B) (90). E B 90 Position the Patella Clamp onto the previously resected patella surface and use the Universal Drill (H) for the anchoring holes. To prepare the seat for the anchoring holes, push the Universal Drill until stop (91). A Patella Trial can now be used (91a). H 91a 91 Instruments 445-902/00 881-012/00 881-511/31 881-501/31 Patella Clamp, Universal Drill, Patella Clamp, Patella Trial, Handle Hudson Fitting (B) Drill Guide size 31 Ø 31 mm 46 Surgical Technique Final Implantation Augment Assembly Select the appropriate sized Femoral/Tibial Components and the matching sized Femoral/Tibial Augment. Using the Tibial and Femoral Trials as a guide, assemble the Femoral and/or Tibial Augment with the Torque Wrench (hex 2.5 mm) (93 & 94). NOTE: Screws are preassembled to the augments. 93 94 Instruments 15-2545 Torque Wrench, hex 2.5 mm 47  Surgical Technique Modular Stem Assembly ATTENTION: Carefully remove the Safety Cap from the taper. The Safety Cap protects the Cone Adapter during transportation (95). 1. 2. ATTENTION: The Cone Adapter is pre-assembled to the Femoral and Tibial implant. ATTENTION: If the Cone Adapter is not assembled or is loose, use the Screwdriver for the Cone Adapt- er to tighten it to the Femoral and Tibial Component (96 & 97). 1. 2. 95 96 97 Select the final femoral and tibial stem, referencing to the ones used for the Trial Assembly. If an Offset Stem is used, insert the male end of the Femoral or Tibial component into the female Offset Stem taper. Referencing the Trial Assembly, align the orientation lines to the appropriate setting (98 & 99). 98 99 Instruments 445-207/00 881-040/99 151-131/00 Impactor/Extractor Tibial Femoral Coupling Base Tip Screwdriver for Cone Adapter Handle 48 Surgical Technique ATTENTION: To avoid a metal on metal contact between the Stem and the Hammer, use the Tibial/Femoral Coupling Base Tip. Connect the Tibial/Femoral Coupling Base Tip with the Impactor/Extractor Handle (100). Slide the Tibial/Femoral Coupling Base Tip onto the top of the Stem. Two Hammer blows are enough (101 & 102). 100 101 102 Secure the Security Screw for the Cone Adapter with the Torque Wrench (hex 2.5 mm) (103 & 104). ATTENTION: The Security Screw is included in the package of the CCK Femoral Component and of the Modular Tibial Component. 103 104 ATTENTION: If a Cemented Stem is used, assemble a Centralizer to the final stem. The Centralizer ensures a central positioning of the stem in the femoral/tibial canal and it avoids stress peaks in the bone in case of bending load. Instruments 445-207/00 881-040/99 15-2545 Impactor/Extractor Tibial Femoral Coupling Base Tip Torque Wrench, hex 2.5 mm Handle 49  Surgical Technique Implantation The implantation sequence: 1 Fixed Bearing Modular Tibial Component Implantation 2 CCK Femoral Component Implantation 3 CCK PE Articulating Surface Implantation 4 Patella Implantation 1 Fixed Bearing Tibial Component Implantation Prepare the sclerotic bone to ensure a continuous cement mantle with good cement interdigitation of 2 mm - 4 mm. This can be done by drilling holes and cleansing the bone with Pulsatile Lavage. The bone cement is prepared following the specific manufacturer's instructions. Apply a layer of bone cement to the underside of the Tibial Component, to the bone, or both. Attach the Tibial Inserter to the fixed bearing tibial implant (105). Carefully insert the Fixed Bearing Tibial Component, avoiding malrotation and impact into place (105). If needed, the Tibial Impactor Tip, assembled with the Impactor/Extractor Handle (106), can be used to com- plete the seating of the component (107). Complete implantation with several hammer blows to the top of Tibial Impactor assembly. Then use a Curette to remove all extruded cement. ATTENTION: Ensure that excess bone cement is completely removed and no loose bone cement particles remain, especially in the posterior part of the joint. OPTIONAL: Attachment for the Quick Connect Handle 105 106 107 Instruments 881-042/00 445-207/00 881-042/99 Tibial Inserter Impactor/Extractor Tibial Impactor Tip Handle 50 Surgical Technique 2 CCK Femoral Component Implantation The bone cement is prepared following the specific manufacturer's instructions. Apply a layer of bone cement to the backside of the Femoral Component, to the bone, or both. Place the selected Femoral Component onto the bone by hand or, if preferred, use the Femoral Inserter/Extractor. Deliver several hammer blows to the Femoral Inserter/Extractor (108). Release the Femoral Inserter/Extractor and use the Femoral Impactor Tip (assembled to the Impactor/Ex- tractor Handle (109) to complete the component impaction (110). Then use a Curette to remove all extruded cement. ATTENTION: Ensure that excess bone cement is completely removed and no loose bone cement particles remain, especially in the posterior part of the joint. 108 109 110 Instruments 445-207/00 881-041/00 881-041/99 Impactor/Extractor Femoral Femoral Impactor Tip Handle Inserter/Extractor 51  Surgical Technique 3 CCK PE Articulating Surface Implantation Select the appropriate size of the CCK PE Articulating Surface. The following table shows the possible LinkSymphoKnee size combinations: CCK Femoral Component 0 1 2 3/3+ 4/4+ 5/5+ 6 7 8 9 10 1 CCK Articulating x x x x x x CCK Articulating Surface 1-2 2 Surface 1-2up x x x x x x Tibial Component 3 x CCK Articulating x x x x CCK Articulating Surface 3-4 4 x Surface 3-4down x x x x 5 x x x x x CCK Articulating Surface 5-6 6 x x x x x 7 x x x x x CCK Articulating Surface 7-8 8 x x x x x 9 x x x x x x x CCK Articulating Surface 9-10 10 x x x x x x x Symbol Description: x = Combination not permitted 52 Surgical Technique Select the appropriate thickness of the Fixed Bearing PE Articulating Surface. The locking mechanism must sit in its resting position before impact. Therefor the following sequences must be followed. Please take particular note that all debris and especially bone cement particles are carefully removed from the surface of the Tibial Component. First the Fixed Bearing PE Articulating Surface is pushed as far posteriorly as it will go before impaction (111a-c). The PE posterior lip must rest beneath the posterior dovetail of the Tibial Component. Then position the Articulating Surface Impactor between 30 and 60 degrees on the insert so that the notch rests on the anterior edge of the center of the insert (111d). Use a mallet to strike the Articulating Surface Impactor. Haptic feedback! The insert is ready for Push the plateau in the tray (90a, 90b) the impact process (111c) 30°- 60° 111a 111 b 111 c Confirm seating by circumferential inspection (111e). 111d 111 e CAUTION: For appropriate insertion of the PE Articulating Surface for LinkSymphoKnee configuration PS, PS+ and CCK, the following aspects are to be considered: Preventing the post-cam mechanism from pushing the PE Articulating Surface out of position. While pushing the insert to its resting position it only can be pushed until reaching the post (111f). If so the tibia has to be moved anteriorly. It can be beneficial to move the knee into extension to help releasing the post cam mechanism. 111f Wrong Right The rotation and the M/L position of the tibia has to be aligned to the femoral component. It is important that the post is proper aligned with the femoral box by internally rotating the tibia (111g). 111 g Instruments 881-040/01 Articulating Surface Impactor 53  Surgical Technique 4 Patella Implantation Insert the Clamp Arm (F) into the first slot from the top of the Patella Clamp Handle (B) (112). F B 112 The bone cement is prepared following the specific manufacturer's instructions. Following extensive rinsing and removal of all impeding soft tissue, the bone cement is applied to the back of the implant, and the implant is placed by hand and pressed on using the Patella Clamp Handle with the Clamp Arm (113). ATTENTION: Ensure that excess bone cement is completely removed and no loose bone cement particles remain in the joint. 113 Functional Test Perform a final functional test through an entire range of motion to check that all components are properly positioned, and also to check for proper ligament tension and patella tracking (114). 114 Instruments 445-902/00 445-904/00 Patella Clamp, Patella Clamp, Arm Handle 54 Surgical Technique Appendix 1, Implant Removal Articulating Surface removal Use the Articulating Surface Extractor to disengage the PE Articulating Surface from the Tibial Component (115). 115 Femoral Component removal Assemble the Slaphammer to the Femoral Inserter/Extractor and use it to extract the Femoral Component (116). ATTENTION: Disrupt cement along the bone interface with flexible osteotomes or thin sawblades with an oscillating saw. NOTE: In the case of a porous component, disrupt the bone/implant interface by using a Gigli saw, the thin blade of a reciprocating saw or flexible osteotomes. 116 Instruments 445-206/00 881-019/00 881-041/00 Slaphammer Articulating Surface Extractor Femoral Inserter/Extractor 55  Surgical Technique Tibial Component removal Assemble the Slaphammer to the Tibial Extractor Tip and use it to extract the Tibial Component (117). Make sure that the Salphammer is fully threaded into the Tibial Extractor Tip, before using the retrograded impactor. 117 Stem removal If the Stem remains in situ, remove all the cement from the noses of the Stem and from the top of the female taper (118) 118 Instruments 445-206/00 881-043/00 Slaphammer Tibial Extractor Tip 56 Surgical Technique Assemble the male taper of the Stem Extractor into the female taper of the stem. ATTENTION: Clean the female taper before inserting the Stem Extractor. ATTENTION: The peg of the Stem Extractor (120) must be on the same side as the marking on the top of the Stem female taper (119). Marking on top of the Stem female taper Peg of the Stem Extractor 119 120 Assemble the Slaphammer onto the Stem Extractor and use it to remove the Stem (121). 121 Instruments 445-206/00 151-144/00 Slaphammer Extractor for Modular Stems/Offset Stems 57  Surgical Technique Appendix 2, Extraction Stem Adapter and Trial Stems: OPTIONAL: If the Trial Stem Adapter and the Trial Stem remain inside the bone during the extraction of the trial components (femoral and/or tibial), it is possible to use the Slaphammer to extract them. Attach the Modular Extractor Tip to the Slaphammer (122). Modular Extractor Tip 122 Connect the Modular Extractor Tip with the Stem Adapter (123). 123 Use the Slaphammer to axially remove the Stem Adapter and the Trial Stem. Instruments 151-132/00 151-716/16 445-206/00 151-501/00 Modular Extractor Tip Trial Stem, cementless, Slaphammer Neutral Stem Adapter cylindrical, Ø 16 mm 58 Surgical Technique Appendix 3, TrabecuLink Cones Compatibility The LinkSymphoKnee CCK Femoral Components and Modular Tibial Components are compatible with the TrabecuLink Femoral Cones and Tibial Cones, respectively (124). 124 Select the appropriate size of the TrabecuLink Femoral Cone according to the following table: Modular Stems LinkSymphoKnee CCK Femoral Component (no offset only) (used with centralizer (with & without slot) Conical Cemented max. Ø 18 mm) cementless Cylindrical conical Femoral 0 1 2 3 3+ 4 4+ 5 5+ 6 7 8 9 10 Cones variant (all sizes) 2-Zones & max. max. 2-Zones Ø 18 Ø 17 Proximal mm mm 3-Zones not compatible Select the appropriate size of the TrabecuLink Tibial Cone according to the following table: Tibial Components Tibial Cones 1 2 3 4 5 6 7 8 9 10 all versions XS x x x x x x x x x x S x x x x x x x x M x x x x x x x x L x x x x x x x x For all TrabecuLink Cones Implants and Instruments information, refer to the TrabecuLink Cones Surgical Technique. 59  Implants Implants Combination Overview Patella Additional Implants CR Femoral Components CR Articulating Surfaces Not modular Tibial Components Additional Implants In the following pages are listed and described all implants and instruments for the CCK configurations. For all other implants and instruments, refer to the LinkSymphoKnee CR, PS, PS+ Surgical Technique. 60 Implants TrabecuLink Femoral Cones Modular Stems and Femoral Augments PS CCK PS PS+ CCK PS All-Poly Modular TrabecuLink Tibial Cones Modular Stems and Tibial Augments 61  Implants LinkSymphoKnee Femoral Components – CCK Micro-Sizes cemented ** ** AP ML AP ML CoCrMo CoCrMo Size Side mm mm LINK PorEx* 880-030/00 880-080/00 0 right 47 53.5 880-030/10 880-080/10 1 right 50 56 880-030/20 880-080/20 2 right 53 58.5 880-031/00 880-081/00 0 left 47 53.5 880-031/10 880-081/10 1 left 50 56 880-031/20 880-081/20 2 left 53 58.5 LinkSymphoKnee Femoral Components – CCK cemented ** ** AP ML AP ML CoCrMo CoCrMo Size Side mm mm LINK PorEx* 880-030/30 880-080/30 3 right 56 61 880-030/40 880-080/40 4 right 59 63.5 880-030/50 880-080/50 5 right 62 66 880-030/60 880-080/60 6 right 65 69 880-030/70 880-080/70 7 right 68 72 880-030/80 880-080/80 8 right 71 75 880-031/30 880-081/30 3 left 56 61 880-031/40 880-081/40 4 left 59 63.5 880-031/50 880-081/50 5 left 62 66 880-031/60 880-081/60 6 left 65 69 880-031/70 880-081/70 7 left 68 72 880-031/80 880-081/80 8 left 71 75    * LINK PorEx: TiNbN = Titanium Niobium Nitride (gold color). ** Cone Adapter made of Tilastan = Ti6Al4V 62 Implants LinkSymphoKnee Femoral Components – CCK Macro-Sizes cemented ** ** AP ML AP ML CoCrMo CoCrMo Size Side mm mm LINK PorEx* 880-030/90 880-080/90 9 right 74 78 880-030/X0 880-080/X0 10 right 77 81 880-031/90 880-081/90 9 left 74 78 880-031/X0 880-081/X0 10 left 77 81 LinkSymphoKnee Femoral Components – CCK Wide-Sizes cemented ** ** AP ML AP ML CoCrMo CoCrMo Size Side mm mm LINK PorEx* 880-030/35 880-080/35 3+ right 56 63.5 880-030/45 880-080/45 4+ right 59 66 880-030/55 880-080/55 5+ right 62 69 880-031/35 880-081/35 3+ left 56 63.5 880-031/45 880-081/45 4+ left 59 66 880-031/55 880-081/55 5+ left 62 69    * LINK PorEx: TiNbN = Titanium Niobium Nitride (gold color). ** Cone Adapter made of Tilastan = Ti6Al4V 63  Implants LinkSymphoKnee Tibial Components – Modular Micro-Sizes cemented AP ** ** ML AP ML CoCrMo CoCrMo Size mm mm LINK PorEx* 880-050/10 880-100/10 1 37.5 59 880-050/20 880-100/20 2 40 62.5 LinkSymphoKnee Tibial Components – Modular cemented AP ** ** ML AP ML CoCrMo CoCrMo Size mm mm LINK PorEx* 880-050/30 880-100/30 3 42.5 66 880-050/40 880-100/40 4 45 69.5 880-050/50 880-100/50 5 47.5 73 880-050/60 880-100/60 6 50 76.5 880-050/70 880-100/70 7 52.5 80 880-050/80 880-100/80 8 55 83.5 LinkSymphoKnee Tibial Components – Modular Macro-Sizes cemented AP ** ** ML AP ML CoCrMo CoCrMo Size mm mm LINK PorEx* 880-050/90 880-100/90 9 57.5 87 880-050/X0 880-100/X0 10 60 90.5    * LINK PorEx: TiNbN = Titanium Niobium Nitride (gold color). ** Cone Adapter made of Tilastan = Ti6Al4V 64 Implants LinkSymphoKnee Articulating Surfaces – CCK Micro-Sizes H AP ML AP ML Height (H) Size UHMWPE E-Dur * mm mm mm 880-231/10 880-271/10 1-2 37.5 59 10 880-231/12 880-271/12 1-2 37.5 59 12 880-231/14 880-271/14 1-2 37.5 59 14 880-231/16 880-271/16 1-2 37.5 59 16 880-231/18 880-271/18 1-2 37.5 59 18 880-231/20 880-271/20 1-2 37.5 59 20 880-231/22 880-271/22 1-2 37.5 59 22 880-231/24 880-271/24 1-2 37.5 59 24 880-232/10 880-272/10 1-2up 37.5 59 10 880-232/12 880-272/12 1-2up 37.5 59 12 880-232/14 880-272/14 1-2up 37.5 59 14 880-232/16 880-272/16 1-2up 37.5 59 16 880-232/18 880-272/18 1-2up 37.5 59 18 880-232/20 880-272/20 1-2up 37.5 59 20 880-232/22 880-272/22 1-2up 37.5 59 22 880-232/24 880-272/24 1-2up 37.5 59 24 * E-Dur = Highly crosslinked UHMWPE (X-Linked PE) with Vit-E 65  Implants LinkSymphoKnee Articulating Surfaces – CCK H AP ML AP ML Height (H) Size UHMWPE E-Dur * mm mm mm 880-233/10 880-273/10 3-4 42.5 66 10 880-233/12 880-273/12 3-4 42.5 66 12 880-233/14 880-273/14 3-4 42.5 66 14 880-233/16 880-273/16 3-4 42.5 66 16 880-233/18 880-273/18 3-4 42.5 66 18 880-233/20 880-273/20 3-4 42.5 66 20 880-233/22 880-273/22 3-4 42.5 66 22 880-233/24 880-273/24 3-4 42.5 66 24 880-234/10 880-274/10 3-4down 42.5 66 10 880-234/12 880-274/12 3-4down 42.5 66 12 880-234/14 880-274/14 3-4down 42.5 66 14 880-234/16 880-274/16 3-4down 42.5 66 16 880-234/18 880-274/18 3-4down 42.5 66 18 880-234/20 880-274/20 3-4down 42.5 66 20 880-234/22 880-274/22 3-4down 42.5 66 22 880-234/24 880-274/24 3-4down 42.5 66 24 880-235/10 880-275/10 5-6 47.5 73 10 880-235/12 880-275/12 5-6 47.5 73 12 880-235/14 880-275/14 5-6 47.5 73 14 880-235/16 880-275/16 5-6 47.5 73 16 880-235/18 880-275/18 5-6 47.5 73 18 880-235/20 880-275/20 5-6 47.5 73 20 880-235/22 880-275/22 5-6 47.5 73 22 880-235/24 880-275/24 5-6 47.5 73 24 880-237/10 880-277/10 7-8 52.5 80 10 880-237/12 880-277/12 7-8 52.5 80 12 880-237/14 880-277/14 7-8 52.5 80 14 880-237/16 880-277/16 7-8 52.5 80 16 880-237/18 880-277/18 7-8 52.5 80 18 880-237/20 880-277/20 7-8 52.5 80 20 880-237/22 880-277/22 7-8 52.5 80 22 880-237/24 880-277/24 7-8 52.5 80 24 LinkSymphoKnee Articulating Surfaces – CCK Macro-Sizes H AP ML AP ML Height (H) Size UHMWPE E-Dur * mm mm mm 880-239/10 880-279/10 9-10 57.5 87 10 880-239/12 880-279/12 9-10 57.5 87 12 880-239/14 880-279/14 9-10 57.5 87 14 880-239/16 880-279/16 9-10 57.5 87 16 880-239/18 880-279/18 9-10 57.5 87 18 880-239/20 880-279/20 9-10 57.5 87 20 880-239/22 880-279/22 9-10 57.5 87 22 880-239/24 880-279/24 9-10 57.5 87 24 * E-Dur = Highly crosslinked UHMWPE (X-Linked PE) with Vit-E 66 Implants LinkSymphoKnee – Cylindrical Press-Fit Stems D1 L LF LT D1 L LF LT Straight 3 mm Offset 6 mm Offset mm mm mm mm Tilastan* Tilastan* Tilastan* 880-601/10 880-611/10 880-621/10 10 80 115 98 880-601/11 880-611/11 880-621/11 11 80 115 98 880-601/12 880-611/12 880-621/12 12 80 115 98 880-601/13 880-611/13 880-621/13 13 80 115 98 880-601/14 880-611/14 880-621/14 14 80 115 98 880-601/15 880-611/15 880-621/15 15 80 115 98 880-601/16 880-611/16 880-621/16 16 80 115 98 880-601/17 880-611/17 880-621/17 17 80 115 98 880-601/18 880-611/18 880-621/18 18 80 115 98 880-603/10 880-613/10 880-623/10 10 120 155 138 880-603/11 880-613/11 880-623/11 11 120 155 138 880-603/12 880-613/12 880-623/12 12 120 155 138 880-603/13 880-613/13 880-623/13 13 120 155 138 880-603/14 880-613/14 880-623/14 14 120 155 138 880-603/15 880-613/15 880-623/15 15 120 155 138 880-603/16 880-613/16 880-623/16 16 120 155 138 880-603/17 880-613/17 880-623/17 17 120 155 138 880-603/18 880-613/18 880-623/18 18 120 155 138 880-603/19 880-613/19 880-623/19 19 120 155 138 880-603/20 880-613/20 880-623/20 20 120 155 138 880-605/11 880-615/11 880-625/11 11 160 195 178 880-605/12 880-615/12 880-625/12 12 160 195 178 880-605/13 880-615/13 880-625/13 13 160 195 178 880-605/14 880-615/14 880-625/14 14 160 195 178 880-605/15 880-615/15 880-625/15 15 160 195 178 880-605/16 880-615/16 880-625/16 16 160 195 178 880-605/17 880-615/17 880-625/17 17 160 195 178 880-605/18 880-615/18 880-625/18 18 160 195 178 880-605/19 880-615/19 880-625/19 19 160 195 178 880-605/20 880-615/20 880-625/20 20 160 195 178 880-607/12 880-617/12 880-627/12 12 200 235 218 880-607/14 880-617/14 880-627/14 14 200 235 218 880-607/16 880-617/16 880-627/16 16 200 235 218 880-607/18 880-617/18 880-627/18 18 200 235 218 880-607/20 880-617/20 880-627/20 20 200 235 218 880-607/22 880-617/22 880-627/22 22 200 235 218 880-608/12 880-618/12 880-628/12 12 220 255 238 880-608/14 880-618/14 880-628/14 14 220 255 238 880-608/16 880-618/16 880-628/16 16 220 255 238 880-608/18 880-618/18 880-628/18 18 220 255 238 880-608/20 880-618/20 880-628/20 20 220 255 238 880-608/22 880-618/22 880-628/22 22 220 255 238 880-609/12 880-619/12 880-629/12 12 240 275 258 880-609/14 880-619/14 880-629/14 14 240 275 258 880-609/16 880-619/16 880-629/16 16 240 275 258 880-609/18 880-619/18 880-629/18 18 240 275 258 880-609/20 880-619/20 880-629/20 20 240 275 258 880-609/22 880-619/22 880-629/22 22 240 275 258 * Tilastan = Ti6Al4V 67  Implants LinkSymphoKnee – Conical Cemented Stems D1 D2 L LF LT D3 CoCrMo C  oCrMo/ 3 mm Offset 3 mm Offset 6 mm Offset 6 mm Offset D1 D2 D3 L LF LT LINK PorEx* C  oCrMo C  oCrMo/ C  oCrMo C  oCrMo/ mm mm mm mm mm mm LINK PorEx* LINK PorEx* 15-2950/17 15-3950/17 16 11 8 50 85 68 15-2950/12 15-3950/12 15-4302/08 15-5302/08 15-4602/08 15-5602/08 16 10 7 80 115 98 15-2950/18 15-3950/18 15-4304/08 15-5304/08 15-4604/08 15-5604/08 16 11 8 80 115 98 15-2950/27 15-3950/27 15-4305/08 15-5305/08 15-4605/08 15-5605/08 16 13 10 80 115 98 15-2950/36 15-3950/36 15-4306/08 15-5306/08 15-4606/08 15-5606/08 16 15 12 80 115 98 15-2950/13 15-3950/13 16 10 7 95 130 113 15-2950/19 15-3950/19 16 11 8 95 130 113 15-2950/28 15-3950/28 16 13 10 95 130 113 15-2950/37 15-3950/37 16 15 12 95 130 113 15-2950/14 15-3950/14 15-4302/12 15-5302/12 15-4602/12 15-5602/12 16 10 7 120 155 138 15-2950/20 15-3950/20 15-4304/12 15-5304/12 15-4604/12 15-5604/12 16 11 8 120 155 138 15-2950/29 15-3950/29 15-4305/12 15-5305/12 15-4605/12 15-5605/12 16 13 10 120 155 138 15-2950/38 15-3950/38 15-4306/12 15-5306/12 15-4606/12 15-5606/12 16 15 12 120 155 138 15-2950/15 15-3950/15 16 10 7 135 170 153 15-2950/21 15-3950/21 16 11 8 135 170 153 15-2950/30 15-3950/30 16 13 10 135 170 153 15-2950/39 15-3950/39 16 15 12 135 170 153 15-2950/16 15-3950/16 15-4302/16 15-5302/16 15-4602/16 15-5602/16 16 10 7 160 195 178 15-2950/22 15-3950/22 15-4304/16 15-5304/16 15-4604/16 15-5604/16 16 11 8 160 195 178 15-2950/31 15-3950/31 15-4305/16 15-5305/16 15-4605/16 15-5605/16 16 13 10 160 195 178 15-2950/40 15-3950/40 15-4306/16 15-5306/16 15-4606/16 15-5606/16 16 15 12 160 195 178 15-2950/44 15-3950/44 15-4304/18 15-5304/18 15-4604/18 15-5604/18 16 11 8 180 215 198 15-2950/45 15-3950/45 15-4305/18 15-5305/18 15-4605/18 15-5605/18 16 13 10 180 215 198 15-2950/46 15-3950/46 15-4306/18 15-5306/18 15-4606/18 15-5606/18 16 15 12 180 215 198 15-2950/23 15-3950/23 16 11 8 200 235 218 15-2950/32 15-3950/32 16 13 10 200 235 218 15-2950/41 15-3950/41 16 15 12 200 235 218 15-2950/24 15-3950/24 15-4304/24 15-5304/24 15-4604/24 15-5604/24 16 11 8 240 275 258 15-2950/33 15-3950/33 15-4305/24 15-5305/24 15-4605/24 15-5605/24 16 13 10 240 275 258 15-2950/42 15-3950/42 15-4306/24 15-5306/24 15-4606/24 15-5606/24 16 15 12 240 275 258 15-2950/25 15-3950/25 16 11 8 280 315 298 15-2950/34 15-3950/34 16 13 10 280 315 298 15-2950/43 15-3950/43 16 15 12 280 315 298 LinkSymphoKnee – Centralizers Ø L Ø Length (L) UHMWPE mm mm 15-2975/12 12 15 15-2975/14 14 15 15-2975/16 16 15 15-2975/18 18 15 15-2975/20 20 15 15-2975/22 22 15 15-2975/24 24 15 * LINK PorEx: TiNbN = Titanium Niobium Nitride (gold color). 68 Implants LinkSymphoKnee – Cylindrical Cementless Stems D1 D2 LF L LT D3 T ilastan* 3 mm Offset 6 mm Offset D1 D2 D3 L LF LT T  ilastan* T  ilastan* mm mm mm mm mm mm 15-2951/43 15-4310/08 15-4610/08 16 10 10 80 115 98 15-2951/44 15-4311/08 15-4611/08 16 11 11 80 115 98 15-2951/45 15-4312/08 15-4612/08 16 12 12 80 115 98 15-2951/46 15-4313/08 15-4613/08 16 13 13 80 115 98 15-2951/47 15-4314/08 15-4614/08 16 14 14 80 115 98 15-2951/48 15-4315/08 15-4615/08 16 15 15 80 115 98 15-2951/49 15-4316/08 15-4616/08 16 16 16 80 115 98 15-2951/50 15-4317/08 15-4617/08 17 17 17 80 115 98 15-2951/51 15-4318/08 15-4618/08 18 18 18 80 115 98 15-2951/54 15-4310/12 15-4610/12 16 10 10 120 155 138 15-2951/55 15-4311/12 15-4611/12 16 11 11 120 155 138 15-2951/72 15-4312/12 15-4612/12 16 12 12 120 155 138 15-2951/56 15-4313/12 15-4613/12 16 13 13 120 155 138 15-2951/78 15-4314/12 15-4614/12 16 14 14 120 155 138 15-2951/57 15-4315/12 15-4615/12 16 15 15 120 155 138 15-2951/84 15-4316/12 15-4616/12 16 16 16 120 155 138 15-2951/58 15-4317/12 15-4617/12 17 17 17 120 155 138 15-2951/90 15-4318/12 15-4618/12 18 18 18 120 155 138 15-2951/59 15-4319/12 15-4619/12 19 19 19 120 155 138 15-2951/60 15-4320/12 15-4620/12 20 20 20 120 155 138 15-2951/63 15-4311/16 15-4611/16 16 11 11 160 195 178 15-2951/73 15-4312/16 15-4612/16 16 12 12 160 195 178 15-2951/64 15-4313/16 15-4613/16 16 13 13 160 195 178 15-2951/79 15-4314/16 15-4614/16 16 14 14 160 195 178 15-2951/65 15-4315/16 15-4615/16 16 15 15 160 195 178 15-2951/85 15-4316/16 15-4616/16 16 16 16 160 195 178 15-2951/66 15-4317/16 15-4617/16 17 17 17 160 195 178 15-2951/91 15-4318/16 15-4618/16 18 18 18 160 195 178 15-2951/67 15-4319/16 15-4619/16 19 19 19 160 195 178 15-2951/68 15-4320/16 15-4620/16 20 20 20 160 195 178 15-2951/74 16 12 12 200 235 218 15-2951/80 16 14 14 200 235 218 15-2951/86 16 16 16 200 235 218 15-2951/92 18 18 18 200 235 218 15-2951/75 16 12 12 240 275 258 15-2951/81 16 14 14 240 275 258 15-2951/87 16 16 16 240 275 258 15-2951/93 18 18 18 240 275 258 * Tilastan = Ti6Al4V 69  Implants LinkSymphoKnee – Conical Cementless Stems D1 D2 L LF LT D3 D1 D2 D3 L LF LT Tilastan* mm mm mm mm mm mm 15-2953/00 16 12 9 128 163 146 15-2953/01 16 13 10 128 163 146 15-2953/02 16 14 11 128 163 146 15-2953/03 16 15 12 128 163 146 15-2953/04 16 16 13 128 163 146 15-2953/05 17 17 14 128 163 146 15-2953/06 18 18 15 128 163 146 15-2953/07 19 19 16 128 163 146 15-2953/08 20 20 17 128 163 146 15-2953/09 21 21 18 128 163 146 15-2953/10 22 22 19 128 163 146 15-2953/11 23 23 20 128 163 146 15-2953/12 24 24 21 128 163 146 15-2954/00 16 12 9 158 193 176 15-2954/01 16 13 10 158 193 176 15-2954/02 16 14 11 158 193 176 15-2954/03 16 15 12 158 193 176 15-2954/04 16 16 13 158 193 176 15-2954/05 17 17 14 158 193 176 15-2954/06 18 18 15 158 193 176 15-2954/07 19 19 16 158 193 176 15-2954/08 20 20 17 158 193 176 15-2954/09 21 21 18 158 193 176 15-2954/10 22 22 19 158 193 176 15-2954/11 23 23 20 158 193 176 15-2954/12 24 24 21 158 193 176 15-2958/00 16 12 9 188 223 206 15-2958/01 16 13 10 188 223 206 15-2958/02 16 14 11 188 223 206 15-2958/03 18 15 12 188 223 206 15-2958/04 16 16 13 188 223 206 15-2958/05 17 17 14 188 223 206 15-2958/06 18 18 15 188 223 206 15-2958/07 19 19 16 188 223 206 15-2958/08 20 20 17 188 223 206 15-2958/09 21 21 18 188 223 206 15-2958/10 22 22 19 188 223 206 15-2958/11 23 23 20 188 223 206 15-2958/12 24 24 21 188 223 206 * Tilastan = Ti6Al4V 70 Implants Replacement Sets for Cone Adapter Tilastan* + CoCrMo T ilastan* + CoCrMo/ LINK PorEx** 15-6118/29 15-6118/30 Each package contains: • One Cone Adapter • Two Security Screws    * Tilastan = Ti6Al4V ** LINK PorEx: TiNbN = Titanium Niobium Nitride (gold color). 71  Implants LinkSymphoKnee Femoral Augments – Distal, Micro-Sizes cemented H H H Height Size Side Tilastan* mm 880-300/11 0 Medial-Right/Lateral-Left 5 880-300/21 0 Lateral-Right/Medial-Left 5 880-301/11 1-2 Medial-Right/Lateral-Left 5 880-301/21 1-2 Lateral-Right/Medial-Left 5 LinkSymphoKnee Femoral Augments – Distal cemented H H H Height Size Side Tilastan* mm 880-303/11 3-4 Medial-Right/Lateral-Left 5 880-303/12 3-4 Medial-Right/Lateral-Left 10 880-303/21 3-4 Lateral-Right/Medial-Left 5 880-303/22 3-4 Lateral-Right/Medial-Left 10 880-305/11 5-6 Medial-Right/Lateral-Left 5 880-305/12 5-6 Medial-Right/Lateral-Left 10 880-305/21 5-6 Lateral-Right/Medial-Left 5 880-305/22 5-6 Lateral-Right/Medial-Left 10 880-307/11 7-8 Medial-Right/Lateral-Left 5 880-307/12 7-8 Medial-Right/Lateral-Left 10 880-307/21 7-8 Lateral-Right/Medial-Left 5 880-307/22 7-8 Lateral-Right/Medial-Left 10 LinkSymphoKnee Femoral Augments – Distal, Macro-Sizes cemented H H H Height Size Side Tilastan* mm 880-309/11 9-10 Medial-Right/Lateral-Left 5 880-309/12 9-10 Medial-Right/Lateral-Left 10 880-309/21 9-10 Lateral-Right/Medial-Left 5 880-309/22 9-10 Lateral-Right/Medial-Left 10 * Tilastan = Ti6Al4V 72 Implants LinkSymphoKnee Femoral Augments – Posterior, Micro-Sizes cemented H H H Height Size Side Tilastan* mm 880-310/11 0 Medial-Right/Lateral-Left 5 880-310/21 0 Lateral-Right/Medial-Left 5 880-311/11 1-2 Medial-Right/Lateral-Left 5 880-311/21 1-2 Lateral-Right/Medial-Left 5 LinkSymphoKnee Femoral Augments – Posterior cemented H H H Height Size Side Tilastan* mm 880-313/11 3-4 Medial-Right/Lateral-Left 5 880-313/12 3-4 Medial-Right/Lateral-Left 10 880-313/21 3-4 Lateral-Right/Medial-Left 5 880-313/22 3-4 Lateral-Right/Medial-Left 10 880-315/11 5-6 Medial-Right/Lateral-Left 5 880-315/12 5-6 Medial-Right/Lateral-Left 10 880-315/21 5-6 Lateral-Right/Medial-Left 5 880-315/22 5-6 Lateral-Right/Medial-Left 10 880-317/11 7-8 Medial-Right/Lateral-Left 5 880-317/12 7-8 Medial-Right/Lateral-Left 10 880-317/21 7-8 Lateral-Right/Medial-Left 5 880-317/22 7-8 Lateral-Right/Medial-Left 10 LinkSymphoKnee Femoral Augments – Posterior, Macro-Sizes cemented H H H Height Size Side Tilastan* mm 880-319/11 9-10 Medial-Right/Lateral-Left 5 880-319/12 9-10 Medial-Right/Lateral-Left 10 880-319/21 9-10 Lateral-Right/Medial-Left 5 880-319/22 9-10 Lateral-Right/Medial-Left 10 * Tilastan = Ti6Al4V 73  Implants LinkSymphoKnee Femoral Augments – L-Shaped, Micro-Sizes cemented H H Height Size Side Tilastan* mm 880-320/12 0 Medial-Right/Lateral-Left 10 880-320/22 0 Lateral-Right/Medial-Left 10 880-321/12 1-2 Medial-Right/Lateral-Left 10 880-321/22 1-2 Lateral-Right/Medial-Left 10 LinkSymphoKnee Femoral Augments – L-Shaped cemented H H Height Size Side Tilastan* mm 880-323/13 3-4 Medial-Right/Lateral-Left 15 880-323/23 3-4 Lateral-Right/Medial-Left 15 880-325/13 5-6 Medial-Right/Lateral-Left 15 880-325/23 5-6 Lateral-Right/Medial-Left 15 880-327/13 7-8 Medial-Right/Lateral-Left 15 880-327/23 7-8 Lateral-Right/Medial-Left 15 LinkSymphoKnee Femoral Augments – L-Shaped, Macro-Sizes cemented H H Height Size Side Tilastan* mm 880-329/13 9-10 Medial-Right/Lateral-Left 15 880-329/23 9-10 Lateral-Right/Medial-Left 15 * Tilastan = Ti6Al4V 74 Implants LinkSymphoKnee Tibial Augments – Micro-Sizes cemented H H H Height Size Side Tilastan* mm 880-331/11 1-2 Medial-Right/Lateral-Left 5 880-331/12 1-2 Medial-Right/Lateral-Left 10 880-331/13 1-2 Medial-Right/Lateral-Left 15 880-331/21 1-2 Lateral-Right/Medial-Left 5 880-331/22 1-2 Lateral-Right/Medial-Left 10 880-331/23 1-2 Lateral-Right/Medial-Left 15 LinkSymphoKnee Tibial Augments cemented H H H Height Size Side Tilastan* mm 880-333/11 3-4 Medial-Right/Lateral-Left 5 880-333/12 3-4 Medial-Right/Lateral-Left 10 880-333/13 3-4 Medial-Right/Lateral-Left 15 880-333/21 3-4 Lateral-Right/Medial-Left 5 880-333/22 3-4 Lateral-Right/Medial-Left 10 880-333/23 3-4 Lateral-Right/Medial-Left 15 880-335/11 5-6 Medial-Right/Lateral-Left 5 880-335/12 5-6 Medial-Right/Lateral-Left 10 880-335/13 5-6 Medial-Right/Lateral-Left 15 880-335/21 5-6 Lateral-Right/Medial-Left 5 880-335/22 5-6 Lateral-Right/Medial-Left 10 880-335/23 5-6 Lateral-Right/Medial-Left 15 880-337/11 7-8 Medial-Right/Lateral-Left 5 880-337/12 7-8 Medial-Right/Lateral-Left 10 880-337/13 7-8 Medial-Right/Lateral-Left 15 880-337/21 7-8 Lateral-Right/Medial-Left 5 880-337/22 7-8 Lateral-Right/Medial-Left 10 880-337/23 7-8 Lateral-Right/Medial-Left 15 LinkSymphoKnee Tibial Augments – Macro-Sizes cemented H H H Height Size Side Tilastan* mm 880-339/11 9-10 Medial-Right/Lateral-Left 5 880-339/12 9-10 Medial-Right/Lateral-Left 10 880-339/13 9-10 Medial-Right/Lateral-Left 15 880-339/21 9-10 Lateral-Right/Medial-Left 5 880-339/22 9-10 Lateral-Right/Medial-Left 10 880-339/23 9-10 Lateral-Right/Medial-Left 15 * Tilastan = Ti6Al4V 75  Implants LinkSymphoKnee Patella Components – 3-peg cemented H Ø Ø Height (H) UHMWPE E-Dur * mm mm 880-501/25 880-511/25 25 6 880-501/28 880-511/28 28 6 880-501/31 880-511/31 31 7 880-501/34 880-511/34 34 8 880-501/37 880-511/37 37 9 880-501/40 880-511/40 40 10 * E-Dur = Highly crosslinked UHMWPE ( X-Linked PE) with Vit-E 76 Instruments LinkSymphoKnee Instrument Sets: Overview CCK CCK CCK CCK CCK Instruments Basic Micro- Macro- Wide- Kit Sizes Sizes Sizes 881-001/00 General Instruments – Blue feet X X X X 881-005/10 CCK Articulating Surface Trials – Yellow feet X X X X 881-006/10 CCK Instruments & Trials – Yellow feet X X X X 881-007/10 CCK Preparation Instruments – Yellow feet X X X X 881-006/00 CCK Instruments & Trials Micro-Sizes – Yellow feet X 881-007/00 CCK Preparation Instruments Micro-Sizes – Yellow feet X 881-006/20 CCK Instruments & Trials Macro-Sizes – Yellow feet X 881-007/20 CCK Preparation Instruments Macro-Sizes – Yellow feet X 881-006/30 CCK Instruments & Trials Wide-Sizes – Yellow feet X Additional Instrument Sets: 881-008/00 Press-Fit Stem Reamers – Yellow feet 881-008/10 Press-Fit Stem Trials – Yellow feet 151-07/00 Ball Reamers & Trial Centralizers – Green feet 151-08/00 Conical Cemented Stem Trials – Yellow feet 151-09/00 Conical Cementless Stem Instruments & Trials, 128 mm – Yellow feet 151-10/00 Conical Cementless Stem Instruments & Trials, 158 mm – Yellow feet 151-11/00 Conical Cementless Stem Instruments & Trials, 188 mm – Yellow feet 881-009/00 Patella Instruments & Trials – Blue feet LinkSymphoKnee Instruments upon request Instruments upon request 445-126/65 Thread Pins, L = 65 mm, Ø 3.0 mm 445-126/95 Thread Pins, L = 95 mm, Ø 3.0 mm 445-127/35 Headed Thread Pins, L = 35 mm, Ø 3.0 mm 445-127/65 Headed Thread Pins, L = 65 mm, Ø 3.0 mm 77  Instruments 881-001/00 General Instruments – Blue feet 1 2 3 4 5 6 16 15 14 13 12 11 10 9 8 7 Z 1 881-010/00 LinkSymphoKnee General Instruments Tray – Upper Tray 1 2 445-206/00 Slaphammer 1 3 16-3283/01 Adapter, Hudson/Jacobs Fitting (E) 1 4 881-012/00 Universal Drill, Hudson Fitting (B) 1 5 445-122/00 Power Driver, Hudson Fitting 1 6 445-122/10 Power Driver with snap lock, Hudson Fitting 1 7 881-011/02 Spacer 4-in-1 Cut, Flexion, H = 10-12 mm 1 8 445-112/00 Handle, Quick Connect 1 9 445-121/00 Pin Inserter, universal 1 10 319-505/00B Step Drill, with Hudson Fitting (B) 1 11 15-2040/02B Twist Drill 3 mm, Hudson Fitting 1 12 317-802/53 Cutting Template 1 13 445-113/10 Alignment Rod, extramedullary, short 1 14 445-113/20 Alignment Rod, extramedullary, long 1 15 445-120/00 Pin Inserter/Extractor, universal 1 16 881-010/02 Spacer Flexion/Extension, H = 10-12 mm 1 78 Instruments 881-001/00 General Instruments – Blue feet 1 2 3 4 5 6 7 8 9 10 11 22 21 20 19 18 17 16 15 14 13 12 Z 1 881-010/00 LinkSymphoKnee General Instruments Tray – Lower Tray 1 2 445-101/00 Intramedullary Rod, Ø 8.0 mm 1 3 881-040/99 Tibial/Femoral Coupling Base Tip 1 4 881-040/01 Articulating Surface Impactor 1 5 15-2545 Torque Wrench, hex 2.5 mm 1 6 881-019/00 Articulating Surface Extractor 1 7 881-043/00 Tibial Extractor Tip 1 8 151-131/00 Screwdriver for Cone Adapter 1 9 881-019/01 Shim, Spacer, H = 1 mm 1 10 881-019/04 Shim, Spacer, H = 4 mm 1 11 881-019/08 Shim, Spacer, H = 8 mm 1 12 445-123/00 Pin Box 1 445-124/65 Drill Pin, L = 65 mm, Ø 3.0 mm 4 445-124/95 Drill Pin, L = 95 mm, Ø 3.0 mm 4 445-125/35 Drill Pin, Headed, L = 35 mm, Ø 3.0 mm 4 445-125/65 Drill Pin, Headed, L = 65 mm, Ø 3.0 mm 4 445-128/25 Bone Nail, L = 25 mm, Ø 3.0 mm 4 445-128/35 Bone Nail, L = 35 mm, Ø 3.0 mm 4 445-128/65 Bone Nail, L = 65 mm, Ø 3.0 mm 4 13 881-042/00 Tibial Inserter 1 14 881-042/90 Tibial Impactor Tip, All Poly 1 15 151-132/00 Modular Extractor Tip 1 16 881-041/99 Femoral Impactor Tip 1 17 881-042/99 Tibial Impactor Tip 1 18 881-053/00 Locking Screw Tibial Plateau, long 1 19 881-052/00 Locking Screw Tibial Plateau, short 1 20 319-601/30 Sterilizing Box, small 1 21 445-207/00 Handle, Impactor/Extractor 1 22 881-041/00 Femoral Inserter/Extractor 1 79  Instruments 881-005/10 CCK Articulating Surface Trials – Yellow feet 1 2-5 6-7 8-11 12-15 16-19 20-21 22-25 26-27 28-31 32-33 34-37 38-39 Z 1 881-050/10 LinkSymphoKnee CCK Articulating Surface Trials Tray 1 2 881-251/10 Trial Plateau, CCK, Size 1-2, H = 10 mm 1 3 881-251/12 Trial Plateau, CCK, Size 1-2, H = 12 mm 1 4 881-251/14 Trial Plateau, CCK, Size 1-2, H = 14 mm 1 5 881-251/16 Trial Plateau, CCK, Size 1-2, H = 16 mm 1 6 881-220/41 Shim, Trial Plateau, H = +4 mm, Size 1-2 1 7 881-250/81 Shim, Trial Plateau, CCK, H = +8 mm, Size 1-2 1 8 881-252/10 Trial Plateau, CCK, Size 1-2up, H = 10 mm 1 9 881-252/12 Trial Plateau, CCK, Size 1-2up, H = 12 mm 1 10 881-252/14 Trial Plateau, CCK, Size 1-2up, H = 14 mm 1 11 881-252/16 Trial Plateau, CCK, Size 1-2up, H = 16 mm 1 12 881-254/10 Trial Plateau, CCK, Size 3-4down, H = 10 mm 1 13 881-254/12 Trial Plateau, CCK, Size 3-4down, H = 12 mm 1 14 881-254/14 Trial Plateau, CCK, Size 3-4down, H = 14 mm 1 15 881-254/16 Trial Plateau, CCK, Size 3-4down, H = 16 mm 1 16 881-253/10 Trial Plateau, CCK, Size 3-4, H = 10 mm 1 17 881-253/12 Trial Plateau, CCK, Size 3-4, H = 12 mm 1 18 881-253/14 Trial Plateau, CCK, Size 3-4, H = 14 mm 1 19 881-253/16 Trial Plateau, CCK, Size 3-4, H = 16 mm 1 20 881-220/43 Shim, Trial Plateau, H= +4 mm, Size 3-4 1 21 881-250/83 Shim, Trial Plateau, CCK, H = +8 mm, Size 3-4 1 22 881-255/10 Trial Plateau, CCK, Size 5-6, H = 10 mm 1 23 881-255/12 Trial Plateau, CCK, Size 5-6, H = 12 mm 1 24 881-255/14 Trial Plateau, CCK, Size 5-6, H = 14 mm 1 25 881-255/16 Trial Plateau, CCK, Size 5-6, H = 16 mm 1 26 881-220/45 Shim, Trial Plateau, H = +4 mm, Size 5-6 1 27 881-250/85 Shim, Trial Plateau, CCK, H = +8 mm, Size 5-6 1 28 881-257/10 Trial Plateau, CCK, Size 7-8, H = 10 mm 1 29 881-257/12 Trial Plateau, CCK, Size 7-8, H = 12 mm 1 30 881-257/14 Trial Plateau, CCK, Size 7-8, H = 14 mm 1 31 881-257/16 Trial Plateau, CCK, Size 7-8, H = 16 mm 1 32 881-220/47 Shim, Trial Plateau, H = +4 mm, Size 7-8 1 33 881-250/87 Shim, Trial Plateau, CCK, H = +8 mm, Size 7-8 1 34 881-259/10 Trial Plateau, CCK, Size 9-10, H = 10 mm 1 35 881-259/12 Trial Plateau, CCK, Size 9-10, H = 12 mm 1 36 881-259/14 Trial Plateau, CCK, Size 9-10, H = 14 mm 1 37 881-259/16 Trial Plateau, CCK, Size 9-10, H = 16 mm 1 38 881-220/49 Shim, Trial Plateau, H = +4 mm, Size 9-10 1 39 881-250/89 Shim, Trial Plateau, CCK, H = +8 mm, Size 9-10 1 80 Instruments 881-006/10 CCK Instruments & Trials – Yellow feet 1 2-8 9 10 11 12 13 14 44 43 15 16 40-42 17 39 36-38 27-35 18-26 Z 1 881-060/10 LinkSymphoKnee CCK Instruments & Trials Tray – Upper Tray 1 2 151-050/12 50 mm Trial Stem Conical Cemented with Ø 12 mm Centralizer 1 3 151-050/14 50 mm Trial Stem Conical Cemented with Ø 14 mm Centralizer 1 4 151-050/16 50 mm Trial Stem Conical Cemented with Ø 16 mm Centralizer 1 5 151-050/18 50 mm Trial Stem Conical Cemented with Ø 18 mm Centralizer 1 6 151-050/20 50 mm Trial Stem Conical Cemented with Ø 20 mm Centralizer 1 7 151-050/22 50 mm Trial Stem Conical Cemented with Ø 22 mm Centralizer 1 8 151-050/24 50 mm Trial Stem Conical Cemented with Ø 24 mm Centralizer 1 9 881-285/30 Tibial Preparation Plate, CCK, Size 3 1 10 881-285/40 Tibial Preparation Plate, CCK, Size 4 1 11 881-285/50 Tibial Preparation Plate, CCK, Size 5 1 12 881-285/60 Tibial Preparation Plate, CCK, Size 6 1 13 881-285/70 Tibial Preparation Plate, CCK, Size 7 1 14 881-285/80 Tibial Preparation Plate, CCK, Size 8 1 15 151-501/00 Neutral Stem Adapter 1 16 881-070/08 Sleeve, Assignment for Intramedullary Rod, Ø 8 mm 1 17 881-067/17 Tapered Reamer, CCK 1 18 881-333/11 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 3-4, H = 5 mm 1 19 881-333/12 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 3-4, H = 10 mm 1 20 881-333/13 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 3-4, H = 15 mm 1 21 881-335/11 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 5-6, H = 5 mm 1 22 881-335/12 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 5-6, H = 10 mm 1 23 881-335/13 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 5-6, H = 15 mm 1 24 881-337/11 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 7-8, H = 5 mm 1 25 881-337/12 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 7-8, H = 10 mm 1 26 881-337/13 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 7-8, H = 15 mm 1 27 881-333/21 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 3-4, H = 5 mm 1 28 881-333/22 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 3-4, H = 10 mm 1 29 881-333/23 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 3-4, H = 15 mm 1 30 881-335/21 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 5-6, H = 5 mm 1 31 881-335/22 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 5-6, H = 10 mm 1 32 881-335/23 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 5-6, H = 15 mm 1 33 881-337/21 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 7-8, H = 5 mm 1 34 881-337/22 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 7-8, H = 10 mm 1 35 881-337/23 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 7-8, H = 15 mm 1 36 151-080/15 80 mm Trial Stem Conical Cemented, Ø 15 mm 1 37 151-095/15 95 mm Trial Stem Conical Cemented, Ø 15 mm 1 38 151-120/15 120 mm Trial Stem Conical Cemented, Ø 15 mm 1 39 881-065/09 Reamer Stopper, Offset 1 40 881-275/34 Tibial Keel Punch, CCK, Size 3-4 1 41 881-275/56 Tibial Keel Punch, CCK, Size 5-6 1 42 881-275/78 Tibial Keel Punch, CCK, Size 7-8 1 43 881-055/00 Neutral Alignment Guide, CCK, 0 mm offset 1 44 881-065/00 Tibial Reamer Guide, CCK 1 81  Instruments 881-006/10 CCK Instruments & Trials – Yellow feet 1 2-7 8 9 10 21-26 11 12 13 15-20 14 Z 1 881-060/10 LinkSymphoKnee CCK Instruments & Trials Tray – Lower Tray 1 2 881-150/30 Femoral Trial, CCK, right, Size 3 1 3 881-150/40 Femoral Trial, CCK, right, Size 4 1 4 881-150/50 Femoral Trial, CCK, right, Size 5 1 5 881-150/60 Femoral Trial, CCK, right, Size 6 1 6 881-150/70 Femoral Trial, CCK, right, Size 7 1 7 881-150/80 Femoral Trial, CCK, right, Size 8 1 8 881-302/91 Femoral Trial Augment, H = 5 mm 4 9 881-302/92 Femoral Trial Augment, H = 10 mm 4 10 881-323/93 Femoral Trial Augment, L-Shaped, Size 3-4, H = 15 mm 2 11 881-325/93 Femoral Trial Augment, L-Shaped, Size 5-6, H = 15 mm 2 12 881-327/93 Femoral Trial Augment, L-Shaped, Size 7-8, H = 15 mm 2 13 319-603/30 Sterilizing Box, medium high 1 14 881-116/00 Reamer Guide, Femoral Box, CCK 1 15 881-151/30 Femoral Trial, CCK, left, Size 3 1 16 881-151/40 Femoral Trial, CCK, left, Size 4 1 17 881-151/50 Femoral Trial, CCK, left, Size 5 1 18 881-151/60 Femoral Trial, CCK, left, Size 6 1 19 881-151/70 Femoral Trial, CCK, left, Size 7 1 20 881-151/80 Femoral Trial, CCK, left, Size 8 1 21 881-258/30 Tibial Trial Component, CCK, Size 3 1 22 881-258/40 Tibial Trial Component, CCK, Size 4 1 23 881-258/50 Tibial Trial Component, CCK, Size 5 1 24 881-258/60 Tibial Trial Component, CCK, Size 6 1 25 881-258/70 Tibial Trial Component, CCK, Size 7 1 26 881-258/80 Tibial Trial Component, CCK, Size 8 1 82 Instruments 881-007/10 CCK Preparation Instruments – Yellow feet 1 2 3 4 5 6 7 8 9 10-11 12-17 18-23 33-35 32 31 30 29 28 27 26 25 24 Z 1 881-070/10 LinkSymphoKnee CCK Preparation Instruments Tray 1 2 151-201/00 Tibial Guide, Intramedullary, 0° 1 3 881-059/00 Tibial Guide, Intramedullary, 3°, CCK 1 4 445-111/00 Stylus, adjustable 1 5 15-6053/00 T-Handle 1 6 151-501/00 Neutral Stem Adapter 2 7 151-803/03 3 mm Offset Adapter 2 8 151-806/06 6 mm Offset Adapter 2 9 881-159/00 Femoral Cutting Block, CCK, Distal Cut 1 10 881-013/16 Shim, Spacer 4-in-1 Cut CCK, Flexion, H = 4 mm 1 11 881-013/20 Shim, Spacer 4-in-1 Cut CCK, Flexion, H = 8 mm 1 12 881-105/30 Femoral Sizer, Template, Size 3, CCK 1 13 881-105/40 Femoral Sizer, Template, Size 4, CCK 1 14 881-105/50 Femoral Sizer, Template, Size 5, CCK 1 15 881-105/60 Femoral Sizer, Template, Size 6, CCK 1 16 881-105/70 Femoral Sizer, Template, Size 7, CCK 1 17 881-105/80 Femoral Sizer, Template, Size 8, CCK 1 18 881-115/30 Femoral Cutting Block, CCK, 4-in-1 Cut, Size 3 1 19 881-115/40 Femoral Cutting Block, CCK, 4-in-1 Cut, Size 4 1 20 881-115/50 Femoral Cutting Block, CCK, 4-in-1 Cut, Size 5 1 21 881-115/60 Femoral Cutting Block, CCK, 4-in-1 Cut, Size 6 1 22 881-115/70 Femoral Cutting Block, CCK, 4-in-1 Cut, Size 7 1 23 881-115/80 Femoral Cutting Block, CCK, 4-in-1 Cut, Size 8 1 24 881-050/06 Femoral Alignment Guide, CCK, Varus/Valgus Adjustment 6°, right 1 25 881-051/06 Femoral Alignment Guide, CCK, Varus/Valgus Adjustment 6°, left 1 26 881-056/00 Trial Stem Rod, Intramedullary 1 27 881-013/00 Spacer 4-in-1 Cut, CCK, Flexion, H = 10-12 mm 1 28 151-144/00 Extractor for Modular Stems/Offset Stems 1 29 881-099/00 Offset Selector, CCK 1 30 151-204/00 Tibial Cutting Block, right 1 31 151-203/00 Tibial Cutting Block, left 1 32 151-202/00 Tibial Guide Connector 1 33 881-114/34 Femoral Box Guide, CCK, Size 3-4 1 34 881-114/56 Femoral Box Guide, CCK, Size 5-6 1 35 881-114/78 Femoral Box Guide, CCK, Size 7-8 1 83  Instruments 881-006/00 CCK Instruments & Trials Micro-Sizes – Yellow feet 1 2 3 4-5 6 7-9 10-12 13-15 16 17 18 19 20 21-23 Z 1 881-060/00 LinkSymphoKnee CCK Instruments & Trials Micro-Sizes Tray 1 2 881-285/10 Tibial Preparation Plate, CCK, Size 1 1 3 881-285/20 Tibial Preparation Plate, CCK, Size 2 1 4 881-258/10 Tibial Trial Component, CCK, Size 1 1 5 881-258/20 Tibial Trial Component, CCK, Size 2 1 6 881-275/12 Tibial Keel Punch, CCK, Size 1-2 1 7 881-150/00 Femoral Trial, CCK, right, Size 0 1 8 881-150/10 Femoral Trial, CCK, right, Size 1 1 9 881-150/20 Femoral Trial, CCK, right, Size 2 1 10 881-331/11 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 1-2, H = 5 mm 1 11 881-331/12 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 1-2, H = 10 mm 1 12 881-331/13 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 1-2, H = 15 mm 1 13 881-331/21 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 1-2, H = 5 mm 1 14 881-331/22 Tibial Trial Augment, Lateral-Right/Lateral-Left, Size 1-2, H = 10 mm 1 15 881-331/23 Tibial Trial Augment, Lateral-Right/Lateral-Left, Size 1-2, H = 15 mm 1 16 881-301/91 Femoral Trial Augment, Micro-Sizes, H = 5 mm 4 17 881-301/92 Femoral Trial Augment, Micro-Sizes, H = 10 mm 4 18 881-320/92 Femoral Trial Augment, L-Shaped, Size 0, H = 10 mm 2 19 881-321/92 Femoral Trial Augment, L-Shaped, Size 1-2, H = 10 mm 2 20 319-603/30 Sterilizing Box, medium high 1 21 881-151/00 Femoral Trial, CCK, left, Size 0 1 22 881-151/10 Femoral Trial, CCK, left, Size 1 1 23 881-151/20 Femoral Trial, CCK, left, Size 2 1 84 Instruments 881-007/00 CCK Preparation Instruments Micro-Sizes – Yellow feet 1 2 3 4 5 10-11 9 6-8 Z 1 881-070/00 LinkSymphoKnee CCK Preparation Instruments Micro-Sizes Tray 1 2 881-105/00 Femoral Sizer, Template, Size 0, CCK 1 3 881-105/10 Femoral Sizer, Template, Size 1, CCK 1 4 881-105/20 Femoral Sizer, Template, Size 2, CCK 1 5 881-010/01 Spacer, Micro-Sizes, Flexion/ Extension, H = 10-12 mm 1 6 881-115/00 Femoral Cutting Block, CCK, 4-in-1 Cut, Size 0 1 7 881-115/10 Femoral Cutting Block, CCK, 4-in-1 Cut, Size 1 1 8 881-115/20 Femoral Cutting Block, CCK, 4-in-1 Cut, Size 2 1 9 881-114/02 Femoral Box Guide, CCK, Size 0-1-2 1 10 881-019/94 Shim, Spacer, H = 4 mm, Micro-Sizes 1 11 881-019/98 Shim, Spacer, H = 8 mm, Micro-Sizes 1 85  Instruments 881-006/20 CCK Instruments & Trials Macro-Sizes – Yellow feet 1 2 3 4-5 6 7 8 9-11 12-14 15 16 17 18 19 20 Z 1 881-060/20 LinkSymphoKnee CCK Instruments & Trials Macro-Sizes Tray 1 2 881-285/90 Tibial Preparation Plate, CCK, Size 9 1 3 881-285/X0 Tibial Preparation Plate, CCK, Size 10 1 4 881-258/90 Tibial Trial Component, CCK, Size 9 1 5 881-258/X0 Tibial Trial Component, CCK, Size 10 1 6 881-275/9X Tibial Keel Punch, CCK, Size 9-10 1 7 881-150/90 Femoral Trial, CCK, right, Size 9 1 8 881-150/X0 Femoral Trial, CCK, right, Size 10 1 9 881-339/11 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 9-10, H = 5 mm 1 10 881-339/12 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 9-10, H = 10 mm 1 11 881-339/13 Tibial Trial Augment, Medial-Right/Lateral-Left, Size 9-10, H = 15 mm 1 12 881-339/21 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 9-10, H = 5 mm 1 13 881-339/22 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 9-10, H = 10 mm 1 14 881-339/23 Tibial Trial Augment, Lateral-Right/Medial-Left, Size 9-10, H = 15 mm 1 15 881-303/91 Femoral Trial Augment, Macro-Sizes, H = 5 mm 4 16 881-303/92 Femoral Trial Augment, Macro-Sizes, H = 10 mm 4 17 881-329/93 Femoral Trial Augment, L-Shaped, Size 9-10, H = 15 mm 2 18 319-603/30 Sterilizing Box, medium high 1 19 881-151/90 Femoral Trial, CCK, left, Size 9 1 20 881-151/X0 Femoral Trial, CCK, left, Size 10 1 86 Instruments 881-007/20 CCK Preparation Instruments Macro-Sizes – Yellow feet 1 2 3 4 5 6 Z 1 881-070/20 LinkSymphoKnee CCK Preparation Instruments Macro-Sizes Tray 1 2 881-105/90 Femoral Sizer, Template, Size 9, CCK 1 3 881-105/X0 Femoral Sizer, Template, Size 10, CCK 1 4 881-115/90 Femoral Cutting Block, CCK, 4-in-1 Cut, Size 9 1 5 881-115/X0 Femoral Cutting Block, CCK, 4-in-1 Cut, Size 10 1 6 881-114/9X Femoral Box Guide, CCK, Size 9-10 1 87  Instruments 881-006/30 CCK Instruments & Trials Wide-Sizes – Yellow feet 1 2 3 4 5 6 7 Z 1 881-060/30 LinkSymphoKnee CCK Instruments & Trials Wide-Sizes Tray 1 2 881-150/35 Femoral Trial, CCK, right, Size 3+ 1 3 881-150/45 Femoral Trial, CCK, right, Size 4+ 1 4 881-150/55 Femoral Trial, CCK, right, Size 5+ 1 5 881-151/35 Femoral Trial, CCK, left, Size 3+ 1 6 881-151/45 Femoral Trial, CCK, left, Size 4+ 1 7 881-151/55 Femoral Trial, CCK, left, Size 5+ 1 88 Instruments 881-008/00 Press-Fit Stem Reamers – Yellow feet 1 2 3 4 5 6 7 8 9 10 11 13 12 Z 1 881-080/00 LinkSymphoKnee Press-Fit Stem Reamers 1 2 881-069/10 Reamer, cementless, cylindrical, Ø 10 mm 1 3 881-069/11 Reamer, cementless, cylindrical, Ø 11 mm 1 4 881-069/12 Reamer, cementless, cylindrical, Ø 12 mm 1 5 881-069/13 Reamer, cementless, cylindrical, Ø 13 mm 1 6 881-069/14 Reamer, cementless, cylindrical, Ø 14 mm 1 7 881-069/15 Reamer, cementless, cylindrical, Ø 15 mm 1 8 881-069/16 Reamer, cementless, cylindrical, Ø 16 mm 1 9 881-069/17 Reamer, cementless, cylindrical, Ø 17 mm 1 10 881-069/18 Reamer, cementless, cylindrical, Ø 18 mm 1 11 881-069/19 Reamer, cementless, cylindrical, Ø 19 mm 1 12 881-069/20 Reamer, cementless, cylindrical, Ø 20 mm 1 13 881-069/22 Reamer, cementless, cylindrical, Ø 22 mm 1 89  Instruments 881-008/10 Press-Fit Stem Trials – Yellow feet 1 2-10 11-21 22-31 Z 1 881-080/10 LinkSymphoKnee Press-Fit Stem Trials – Upper Tray 1 2 151-780/10 Trial Stem, cementless, cylindrical, Ø 10 mm, Stem.L 80 mm 1 3 151-780/11 Trial Stem, cementless, cylindrical, Ø 11 mm, Stem.L 80 mm 1 4 151-780/12 Trial Stem, cementless, cylindrical, Ø 12 mm, Stem.L 80 mm 1 5 151-780/13 Trial Stem, cementless, cylindrical, Ø 13 mm, Stem.L 80 mm 1 6 151-780/14 Trial Stem, cementless, cylindrical, Ø 14 mm, Stem.L 80 mm 1 7 151-780/15 Trial Stem, cementless, cylindrical, Ø 15 mm, Stem.L 80 mm 1 8 151-780/16 Trial Stem, cementless, cylindrical, Ø 16 mm, Stem.L 80 mm 1 9 151-780/17 Trial Stem, cementless, cylindrical, Ø 17 mm, Stem.L 80 mm 1 10 151-780/18 Trial Stem, cementless, cylindrical, Ø 18 mm, Stem.L 80 mm 1 11 151-712/10 Trial Stem, cementless, cylindrical, Ø 10 mm, Stem.L 120 mm 1 12 151-712/11 Trial Stem, cementless, cylindrical, Ø 11 mm, Stem.L 120 mm 1 13 151-712/12 Trial Stem, cementless, cylindrical, Ø 12 mm, Stem.L 120 mm 1 14 151-712/13 Trial Stem, cementless, cylindrical, Ø 13 mm, Stem.L 120 mm 1 15 151-712/14 Trial Stem, cementless, cylindrical, Ø 14 mm, Stem.L 120 mm 1 16 151-712/15 Trial Stem, cementless, cylindrical, Ø 15 mm, Stem.L 120 mm 1 17 151-712/16 Trial Stem, cementless, cylindrical, Ø 16 mm, Stem.L 120 mm 1 18 151-712/17 Trial Stem, cementless, cylindrical, Ø 17 mm, Stem.L 120 mm 1 19 151-712/18 Trial Stem, cementless, cylindrical, Ø 18 mm, Stem.L 120 mm 1 20 151-712/19 Trial Stem, cementless, cylindrical, Ø 19 mm, Stem.L 120 mm 1 21 151-712/20 Trial Stem, cementless, cylindrical, Ø 20 mm, Stem.L 120 mm 1 22 151-716/11 Trial Stem, cementless, cylindrical, Ø 11 mm, Stem.L 160 mm 1 23 151-716/12 Trial Stem, cementless, cylindrical, Ø 12 mm, Stem.L 160 mm 1 24 151-716/13 Trial Stem, cementless, cylindrical, Ø 13 mm, Stem.L 160 mm 1 25 151-716/14 Trial Stem, cementless, cylindrical, Ø 14 mm, Stem.L 160 mm 1 26 151-716/15 Trial Stem, cementless, cylindrical, Ø 15 mm, Stem.L 160 mm 1 27 151-716/16 Trial Stem, cementless, cylindrical, Ø 16 mm, Stem.L 160 mm 1 28 151-716/17 Trial Stem, cementless, cylindrical, Ø 17 mm, Stem.L 160 mm 1 29 151-716/18 Trial Stem, cementless, cylindrical, Ø 18 mm, Stem.L 160 mm 1 30 151-716/19 Trial Stem, cementless, cylindrical, Ø 19 mm, Stem.L 160 mm 1 31 151-716/20 Trial Stem, cementless, cylindrical, Ø 20 mm, Stem.L 160 mm 1 90 Instruments 881-008/10 Press-Fit Stem Trials – Yellow feet 1 2-7 8-13 14-19 Z 1 881-080/10 LinkSymphoKnee Press-Fit Stem Trials – Lower Tray 1 2 151-720/12 Trial Stem, cementless, cylindrical, Ø 12 mm, Stem.L 200 mm 1 3 151-720/14 Trial Stem, cementless, cylindrical, Ø 14 mm, Stem.L 200 mm 1 4 151-720/16 Trial Stem, cementless, cylindrical, Ø 16 mm, Stem.L 200 mm 1 5 151-720/18 Trial Stem, cementless, cylindrical, Ø 18 mm, Stem.L 200 mm 1 6 151-720/20 Trial Stem, cementless, cylindrical, Ø 20 mm, Stem.L 200 mm 1 7 151-720/22 Trial Stem, cementless, cylindrical, Ø 22 mm, Stem.L 200 mm 1 8 151-722/12 Trial Stem, cementless, cylindrical, Ø 12 mm, Stem.L 220 mm 1 9 151-722/14 Trial Stem, cementless, cylindrical, Ø 14 mm, Stem.L 220 mm 1 10 151-722/16 Trial Stem, cementless, cylindrical, Ø 16 mm, Stem.L 220 mm 1 11 151-722/18 Trial Stem, cementless, cylindrical, Ø 18 mm, Stem.L 220 mm 1 12 151-722/20 Trial Stem, cementless, cylindrical, Ø 20 mm, Stem.L 220 mm 1 13 151-722/22 Trial Stem, cementless, cylindrical, Ø 22 mm, Stem.L 220 mm 1 14 151-724/12 Trial Stem, cementless, cylindrical, Ø 12 mm, Stem.L 240 mm 1 15 151-724/14 Trial Stem, cementless, cylindrical, Ø 14 mm, Stem.L 240 mm 1 16 151-724/16 Trial Stem, cementless, cylindrical, Ø 16 mm, Stem.L 240 mm 1 17 151-724/18 Trial Stem, cementless, cylindrical, Ø 18 mm, Stem.L 240 mm 1 18 151-724/20 Trial Stem, cementless, cylindrical, Ø 20 mm, Stem.L 240 mm 1 19 151-724/22 Trial Stem, cementless, cylindrical, Ø 22 mm, Stem.L 240 mm 1 91  Instruments 151-07/00 Ball Reamers & Trial Centralizers – Green feet 1 2-8 9 10 11 12 13 14 15 16 17 Z 1 151-07/07 Ball Reamers & Trial Centralizers Tray 1 2 151-106/12 Trial Centralizer, 12 mm 2 3 151-106/14 Trial Centralizer, 14 mm 2 4 151-106/16 Trial Centralizer, 16 mm 2 5 151-106/18 Trial Centralizer, 18 mm 2 6 151-106/20 Trial Centralizer, 20 mm 2 7 151-106/22 Trial Centralizer, 22 mm 2 8 151-106/24 Trial Centralizer, 24 mm 2 9 15-1133/02B Ball Reamer, 10 mm 1 10 15-1133/03B Ball Reamer, 12 mm 1 11 15-1133/04B Ball Reamer, 14 mm 1 12 15-1133/05B Ball Reamer, 16 mm 1 13 15-1133/06B Ball Reamer, 18 mm 1 14 15-1133/07B Ball Reamer, 20 mm 1 15 15-1133/08B Ball Reamer, 22 mm 1 16 15-1133/09B Ball Reamer, 24 mm 1 17 15-1133/10B Ball Reamer, 26 mm 1 92 Instruments 151-08/00 Conical Cemented Stem Trials – Yellow feet 1 2-5 6-9 10-13 14-17 18-21 28-30 34-40 21-24 25-27 31-33 Z 1 151-08/08 Conical Cemented Stem Trials Tray 1 2 151-080/10 Trial Stem Conical Cemented, Ø 10 mm, 80 mm 1 3 151-080/11 Trial Stem Conical Cemented, Ø 11 mm, 80 mm 1 4 151-080/13 Trial Stem Conical Cemented, Ø 13 mm, 80 mm 1 5 151-080/15 Trial Stem Conical Cemented, Ø 15 mm, 80 mm 1 6 151-095/10 Trial Stem Conical Cemented, Ø 10 mm, 95 mm 1 7 151-095/11 Trial Stem Conical Cemented, Ø 11 mm, 95 mm 1 8 151-095/13 Trial Stem Conical Cemented, Ø 13 mm, 95 mm 1 9 151-095/15 Trial Stem Conical Cemented, Ø 15 mm, 95 mm 1 10 151-120/10 Trial Stem Conical Cemented, Ø 10 mm, 120 mm 1 11 151-120/11 Trial Stem Conical Cemented, Ø 11 mm, 120 mm 1 12 151-120/13 Trial Stem Conical Cemented, Ø 13 mm, 120 mm 1 13 151-120/15 Trial Stem Conical Cemented, Ø 15 mm, 120 mm 1 14 151-135/10 Trial Stem Conical Cemented, Ø 10 mm, 135 mm 1 15 151-135/11 Trial Stem Conical Cemented, Ø 11 mm, 135 mm 1 16 151-135/13 Trial Stem Conical Cemented, Ø 13 mm, 135 mm 1 17 151-135/15 Trial Stem Conical Cemented, Ø 15 mm, 135 mm 1 18 151-160/10 Trial Stem Conical Cemented, Ø 10 mm, 160 mm 1 19 151-160/11 Trial Stem Conical Cemented, Ø 11 mm, 160 mm 1 20 151-160/13 Trial Stem Conical Cemented, Ø 13 mm, 160 mm 1 21 151-160/15 Trial Stem Conical Cemented, Ø 15 mm, 160 mm 1 22 151-180/11 Trial Stem Conical Cemented, Ø 11 mm, 180 mm 1 23 151-180/13 Trial Stem Conical Cemented, Ø 13 mm, 180 mm 1 24 151-180/15 Trial Stem Conical Cemented, Ø 15 mm, 180 mm 1 25 151-200/11 Trial Stem Conical Cemented, Ø 11 mm, 200 mm 1 26 151-200/13 Trial Stem Conical Cemented, Ø 13 mm, 200 mm 1 27 151-200/15 Trial Stem Conical Cemented, Ø 15 mm, 200 mm 1 28 151-240/11 Trial Stem Conical Cemented, Ø 11 mm, 240 mm 1 29 151-240/13 Trial Stem Conical Cemented, Ø 13 mm, 240 mm 1 30 151-240/15 Trial Stem Conical Cemented, Ø 15 mm, 240 mm 1 31 151-280/11 Trial Stem Conical Cemented, Ø 11 mm, 280 mm 1 32 151-280/13 Trial Stem Conical Cemented, Ø 13 mm, 280 mm 1 33 151-280/15 Trial Stem Conical Cemented, Ø 15 mm, 280 mm 1 34 151-050/12 Trial Stem Conical Cemented, Ø 11 mm with Ø 12 mm Centralizer, 50 mm 1 35 151-050/14 Trial Stem Conical Cemented, Ø 11 mm with Ø 14 mm Centralizer, 50 mm 1 36 151-050/16 Trial Stem Conical Cemented, Ø 11 mm with Ø 16 mm Centralizer, 50 mm 1 37 151-050/18 Trial Stem Conical Cemented, Ø 11 mm with Ø 18 mm Centralizer, 50 mm 1 38 151-050/20 Trial Stem Conical Cemented, Ø 11 mm with Ø 20 mm Centralizer, 50 mm 1 39 151-050/22 Trial Stem Conical Cemented, Ø 11 mm with Ø 22 mm Centralizer, 50 mm 1 40 151-050/24 Trial Stem Conical Cemented, Ø 11 mm with Ø 24 mm Centralizer, 50 mm 1 93  Instruments 151-09/00 Conical Cementless Stem Instruments & Trials, 128 mm – Yellow feet 1 2 3 4 5 6 7 9 11 8 10 12 13 15 19 17 14 16 18 Z 1 151-09/09 Conical Cementless Stem Instruments & Trials, 128 mm Tray – Upper Tray 1 2 151-718/00 Reamer Stopper, Tibia, XS-L 2 3 151-719/00 Reamer Stopper, Femur, XS 2 4 151-719/01 Reamer Stopper, Femur, S 2 5 151-719/02 Reamer Stopper, Femur, M 2 6 151-719/03 Reamer Stopper, Femur, L 2 7 151-100/12 Trial Stem Conical, Cementless, 128 mm, Ø 12 mm 1 8 151-100/13 Trial Stem Conical, Cementless, 128 mm, Ø 13 mm 1 9 151-100/14 Trial Stem Conical, Cementless, 128 mm, Ø 14 mm 1 10 151-100/15 Trial Stem Conical, Cementless, 128 mm, Ø 15 mm 1 11 151-100/16 Trial Stem Conical, Cementless, 128 mm, Ø 16 mm 1 12 151-100/17 Trial Stem Conical, Cementless, 128 mm, Ø 17 mm 1 13 151-100/18 Trial Stem Conical, Cementless, 128 mm, Ø 18 mm 1 14 151-100/19 Trial Stem Conical, Cementless, 128 mm, Ø 19 mm 1 15 151-100/20 Trial Stem Conical, Cementless, 128 mm, Ø 20 mm 1 16 151-100/21 Trial Stem Conical, Cementless, 128 mm, Ø 21 mm 1 17 151-100/22 Trial Stem Conical, Cementless, 128 mm, Ø 22 mm 1 18 151-100/23 Trial Stem Conical, Cementless, 128 mm, Ø 23 mm 1 19 151-100/24 Trial Stem Conical, Cementless, 128 mm, Ø 24 mm 1 94 Instruments 151-09/00 Conical Cementless Stem Instruments & Trials, 128 mm – Yellow feet 1 2 4 6 8 10 3 5 7 9 11 12 14 13 Z 1 151-09/09 Conical Cementless Stem Instruments & Trials, 128 mm Tray – Lower Tray 1 2 151-610/12 Reamer Conical, 128 mm, Ø 12 mm 1 3 151-610/13 Reamer Conical, 128 mm, Ø 13 mm 1 4 151-610/14 Reamer Conical, 128 mm, Ø 14 mm 1 5 151-610/15 Reamer Conical, 128 mm, Ø 15 mm 1 6 151-610/16 Reamer Conical, 128 mm, Ø 16 mm 1 7 151-610/17 Reamer Conical, 128 mm, Ø 17 mm 1 8 151-610/18 Reamer Conical, 128 mm, Ø 18 mm 1 9 151-610/19 Reamer Conical, 128 mm, Ø 19 mm 1 10 151-610/20 Reamer Conical, 128 mm, Ø 20 mm 1 11 151-610/21 Reamer Conical, 128 mm, Ø 21 mm 1 12 151-610/22 Reamer Conical, 128 mm, Ø 22 mm 1 13 151-610/23 Reamer Conical, 128 mm, Ø 23 mm 1 14 151-610/24 Reamer Conical, 128 mm, Ø 24 mm 1 95  Instruments 151-10/00 Conical Cementless Stem Instruments & Trials, 158 mm – Yellow feet 1 2 3 4 5 6 7 9 11 8 10 12 13 15 19 17 14 16 18 Z 1 151-10/10 Conical Cementless Stem Instruments & Trials, 158 mm Tray – Upper Tray 1 2 151-718/00 Reamer Stopper, Tibia, XS-L 2 3 151-719/00 Reamer Stopper, Femur, XS 2 4 151-719/01 Reamer Stopper, Femur, S 2 5 151-719/02 Reamer Stopper, Femur, M 2 6 151-719/03 Reamer Stopper, Femur, L 2 7 151-130/12 Trial Stem Conical, Cementless, 158 mm, Ø 12 mm 1 8 151-130/13 Trial Stem Conical, Cementless, 158 mm, Ø 13 mm 1 9 151-130/14 Trial Stem Conical, Cementless, 158 mm, Ø 14 mm 1 10 151-130/15 Trial Stem Conical, Cementless, 158 mm, Ø 15 mm 1 11 151-130/16 Trial Stem Conical, Cementless, 158 mm, Ø 16 mm 1 12 151-130/17 Trial Stem Conical, Cementless, 158 mm, Ø 17 mm 1 13 151-130/18 Trial Stem Conical, Cementless, 158 mm, Ø 18 mm 1 14 151-130/19 Trial Stem Conical, Cementless, 158 mm, Ø 19 mm 1 15 151-130/20 Trial Stem Conical, Cementless, 158 mm, Ø 20 mm 1 16 151-130/21 Trial Stem Conical, Cementless, 158 mm, Ø 21 mm 1 17 151-130/22 Trial Stem Conical, Cementless, 158 mm, Ø 22 mm 1 18 151-130/23 Trial Stem Conical, Cementless, 158 mm, Ø 23 mm 1 19 151-130/24 Trial Stem Conical, Cementless, 158 mm, Ø 24 mm 1 96 Instruments 151-10/00 Conical Cementless Stem Instruments & Trials, 158 mm – Yellow feet 1 2 4 6 8 10 3 5 7 9 11 12 14 13 Z 1 151-10/10 Conical Cementless Stem Instruments & Trials, 158 mm Tray – Lower Tray 1 2 151-613/12 Reamer Conical, 158 mm, Ø 12 mm 1 3 151-613/13 Reamer Conical, 158 mm, Ø 13 mm 1 4 151-613/14 Reamer Conical, 158 mm, Ø 14 mm 1 5 151-613/15 Reamer Conical, 158 mm, Ø 15 mm 1 6 151-613/16 Reamer Conical, 158 mm, Ø 16 mm 1 7 151-613/17 Reamer Conical, 158 mm, Ø 17 mm 1 8 151-613/18 Reamer Conical, 158 mm, Ø 18 mm 1 9 151-613/19 Reamer Conical, 158 mm, Ø 19 mm 1 10 151-613/20 Reamer Conical, 158 mm, Ø 20 mm 1 11 151-613/21 Reamer Conical, 158 mm, Ø 21 mm 1 12 151-613/22 Reamer Conical, 158 mm, Ø 22 mm 1 13 151-613/23 Reamer Conical, 158 mm, Ø 23 mm 1 14 151-613/24 Reamer Conical, 158 mm, Ø 24 mm 1 97  Instruments 151-11/00 Conical Cementless Stem Instruments & Trials, 188 mm – Yellow feet 1 2 3 4 5 6 7 9 11 8 10 12 13 15 17 19 14 16 18 Z 1 151-11/11 Conical Cementless Stem Instruments & Trials, 188 mm Tray – Upper Tray 1 2 151-718/00 Reamer Stopper, Tibia, XS-L 2 3 151-719/00 Reamer Stopper, Femur, XS 2 4 151-719/01 Reamer Stopper, Femur, S 2 5 151-719/02 Reamer Stopper, Femur, M 2 6 151-719/03 Reamer Stopper, Femur, L 2 7 151-160/12 Trial Stem Conical, Cementless, 188 mm, Ø 12 mm 1 8 151-016/13 Trial Stem Conical, Cementless, 188 mm, Ø 13 mm 1 9 151-160/14 Trial Stem Conical, Cementless, 188 mm, Ø 14 mm 1 10 151-016/15 Trial Stem Conical, Cementless, 188 mm, Ø 15 mm 1 11 151-160/16 Trial Stem Conical, Cementless, 188 mm, Ø 16 mm 1 12 151-160/17 Trial Stem Conical, Cementless, 188 mm, Ø 17 mm 1 13 151-160/18 Trial Stem Conical, Cementless, 188 mm, Ø 18 mm 1 14 151-160/19 Trial Stem Conical, Cementless, 188 mm, Ø 19 mm 1 15 151-160/20 Trial Stem Conical, Cementless, 188 mm, Ø 20 mm 1 16 151-160/21 Trial Stem Conical, Cementless, 188 mm, Ø 21 mm 1 17 151-160/22 Trial Stem Conical, Cementless, 188 mm, Ø 22 mm 1 18 151-160/23 Trial Stem Conical, Cementless, 188 mm, Ø 23 mm 1 19 151-160/24 Trial Stem Conical, Cementless, 188 mm, Ø 24 mm 1 98 Instruments 151-11/00 Conical Cementless Stem Instruments & Trials, 188 mm – Yellow feet 1 2 4 6 8 10 3 5 7 9 11 12 14 13 Z 1 151-11/11 Conical Cementless Stem Instruments & Trials, 188 mm Tray – Lower Tray 1 2 151-616/12 Reamer Conical, 188 mm, Ø 12 mm 1 3 151-616/13 Reamer Conical, 188 mm, Ø 13 mm 1 4 151-616/14 Reamer Conical, 188 mm, Ø 14 mm 1 5 151-616/15 Reamer Conical, 188 mm, Ø 15 mm 1 6 151-616/16 Reamer Conical, 188 mm, Ø 16 mm 1 7 151-616/17 Reamer Conical, 188 mm, Ø 17 mm 1 8 151-616/18 Reamer Conical, 188 mm, Ø 18 mm 1 9 151-616/19 Reamer Conical, 188 mm, Ø 19 mm 1 10 151-616/20 Reamer Conical, 188 mm, Ø 20 mm 1 11 151-616/21 Reamer Conical, 188 mm, Ø 21 mm 1 12 151-616/22 Reamer Conical, 188 mm, Ø 22 mm 1 13 151-616/23 Reamer Conical, 188 mm, Ø 23 mm 1 14 151-616/24 Reamer Conical, 188 mm, Ø 24 mm 1 99  Instruments 881-009/00 Patella Instruments & Trials – Blue feet 2 3-5 6-8 9 10-15 1 16 17 19 18 Z 1 881-090/00 LinkSymphoKnee Patella Instruments & Trials Tray 1 2 881-012/00 Universal Drill, Hudson Fitting (B) 1 3 881-501/25 Patella Trial, Ø 25 mm, H = 6 mm 1 4 881-501/28 Patella Trial, Ø 28 mm, H = 6 mm 1 5 881-501/31 Patella Trial, Ø 31 mm, H = 7 mm 1 6 881-501/34 Patella Trial, Ø 34 mm, H = 8 mm 1 7 881-501/37 Patella Trial, Ø 37 mm, H = 9 mm 1 8 881-501/40 Patella Trial, Ø 40 mm, H = 10 mm 1 9 445-904/00 Patella Clamp, Clamp Arm 1 10 881-511/25 Patella Drill Guide, Ø 25 mm 1 11 881-511/28 Patella Drill Guide, Ø 28 mm 1 12 881-511/31 Patella Drill Guide, Ø 31 mm 1 13 881-511/34 Patella Drill Guide, Ø 34 mm 1 14 881-511/37 Patella Drill Guide, Ø 37 mm 1 15 881-511/40 Patella Drill Guide, Ø 40 mm 1 16 881-509/00 Patella Sizing Template 1 17 445-903/00 Patella Clamp, Resection Guide 1 18 445-902/00 Patella Clamp, Handle 1 19 881-500/00 Patella Depth Gauge 1 100 Instruments Additional Instruments Hudson Fitting (B) Standard tool connection. Adapter for power tool chuck Different adapters are available to ensure compatibility to allow various connections: Attachment 16-3283/01 Jacobs Fitting (E) 16-3284/00 AO Fitting (D) 16-3285/00 Harris Fitting (C) A Sawblades, without offset teeth, 1.24 mm thick Width (A) Width (A) Fitting 25 mm 13 mm 317-654/10 317-656/10 Synthes 317-654/11 317-656/11 Aesculap Combi Zimmer / Hall 317-654/13 317-656/13 Combi 317-654/14 317-656/14 Stryker System 4 X-ray Templates X-ray Templates for LinkSymphoKnee CCK 881-750/00 To be used with LinkSymphoKnee CCK, 110% actual size 101  Additional Information For more information please register for our LINK Media Library (linkorthopaedics.com) 102 Indications/Contraindications Specified Indications and Contraindications: LinkSymphoKnee System General Indications: The LinkSymphoKnee System is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: Primary degenerative arthritis/osteoarthritis Secondary arthritis resulting from rheumatoid arthritis Fracture Contraindications (absolute): All LinkSymphoKnee Designs Acute and chronic infections, local and systemic, insofar as they may compromise the successful implantation Any bone defect that will result in insufficient implant fixation (based on the fact, that using stems, bone grafts and metal bone substitutes like cones, a minimum bone stock for implant fixation cannot be defined) Severe insufficiency or loss of extensor mechanism LinkSymphoKnee Cruciate Retaining Fixed Bearing (CR FB) Moderate or severe instability or complete loss of the medial or collateral ligament Instability or loss of the posterior cruciate ligament LinkSymphoKnee Posterior Stabilized Fixed Bearing and All-Poly (PS FB and PS All-Poly) Moderate or severe instability or complete loss of the medial or collateral ligament LinkSymphoKnee Posterior Stabilized Plus Fixed Bearing (PS+ FB) Severe instability or complete loss of the medial or collateral ligament LinkSymphoKnee Condylar Constrained Knee Fixed Bearing (CCK FB) Complete loss of the medial or lateral collateral ligament Contraindications (relative): All LinkSymphoKnee Designs Allergy to one of the implant materials LinkSymphoKnee Cruciate Retaining Fixed Bearing (CR FB) Extension deficit >30° Varus or valgus deformity >30° LinkSymphoKnee Posterior Stabilized Plus Fixed Bearing (PS+ FB) Situations in which an overall leg alignment will result, that is outside a range of 5° varus or valgus in reference to the mechanical axis. In such a situation the PS+ mechanism may fail over time as a result of the shear forces. LinkSymphoKnee Condylar Constrained Knee Fixed Bearing (CCK FB) Situations in which an overall leg alignment will result, that is outside a range of 5° varus or valgus in reference to the mechanical axis. In such a situation the CC mechanism may fail over time as a result of the shear forces Please note: These indications/contraindications refer to standard cases. The ultimate decision on whether or not an implant is suitable for a patient must be made by the surgeon based on his/her individual analysis and his/her experience. 103  Notes 104 Important Information Please note the following regarding the use of our implants: 1. Choosing the right implant is very important. The size and shape of the human bone determines the size and shape of the implant and also limits the load capacity. Implants are not designed to withstand unlimited physical stress. Demands should not exceed normal functional loads. 2. Correct handling of the implant is very important. Under no circumstances should the shape of a finished implant be altered, as this shortens its life span. Our implants must not be combined with implants from other manufacturers. The instruments indicated in the Surgical Technique must be used to ensure safe implantation of the components. 3. Implants must not be reused. Implants are supplied sterile and are intended for single use only. Used implants must not be used again. 4. After-treatment is also very important. The patient must be informed of the limitations of the implant. The load capacity of an implant cannot compare with that of healthy bone! 5. Unless otherwise indicated, implants are supplied in sterile packaging. Note the following conditions for storage of packaged implants: • Avoid extreme or sudden changes in temperature. • Sterile implants in their original, intact protective packaging may be stored in permanent buildings up until the “Use by” date indicated on the packaging. • They must not be exposed to frost, dampness or direct sunlight, or mechanical damage. • Implants may be stored in their original packaging for up to 5 years after the date of manufacture. The “Use by” date is indicated on the product label. • Do not use an implant if the packaging is damaged. 6. Traceability is important. Please use the documentation stickers provided to ensure traceability. 7. Further information on the material composition is available on request from the manufacturer. Follow the instructions for use! Waldemar Link GmbH & Co. KG, Hamburg All content in this catalog, including text, pictures and data, is protected by law. Every instance of use, whether in part or in whole and which is not permitted by law, is subject to our prior consent. In particular, this applies to the reproduction, editing, translation, publishing, saving, processing, or passing on of content stored in databases or other electronic media and systems, in any manner or form. The information in the catalogs is solely intended to describe the products and does not constitute a guarantee. The Surgical Technique described has been written to the best of our knowledge and belief, but it does not relieve the surgeon of his/her responsibility to duly consider the particularities of each individual case. Products shown in this document may not be available in your country. The product availability is subject to the approval and/or registration regulations of the respective country. Please contact Waldemar Link GmbH & Co. KG if you have questions about the availability of LINK products in your country. Waldemar Link GmbH & Co. KG and/or other corporate affiliated entities own, use or have applied for the following trademarks in many jurisdictions: LINK, BiMobile, SP II, Modell Lubinus, E-Dur, EndoDur, T.O.P. II, BetaCup, CombiCup PF, CombiCup SC, CombiCup R, MobileLink, C.F.P., LCU, SP-CL, LCP, MIT-H, Endo-Model, Endo-Model SL, MP, MEGASYSTEM-C, GEMINI SL, SPAR-K, LCK, HX, TiCaP, X-LINKed, PorAg, LINK PorEx, BiPorEx, PorEx-Z, TrabecuLink, Tilastan, customLINK, RescueSleeve, Stactip, VACUCAST. Other trademarks and trade names may be used in this document to refer to either the entities claiming the marks and/or names or their products and are the property of their respective owners. © LINK • 7501_LSK-CCK_OP-Impl-Instr_us_2022-10_003 B MAR-02836 3.0 This publication is intended for distribution in the U.S. only. Waldemar Link GmbH & Co. KG Barkhausenweg 10 · 22339 Hamburg · Germany Phone +49 40 53995-0 · [email protected] www.linkorthopaedics.com  OXINIUM Technology in Knees THE MOMENT F CHANGE Changing times, changing needs It’s time to change everything As the number of cases and the age of patients broadens,1-3 orthopaedic applications demand a high performance implant material that can deliver proven clinical performance in hip and knee arthroplasty.4-8 But what does real change look like? At Smith+Nephew, we know you want the best possible clinical outcomes for your knee replacement patients. In order to do that, you need to have confidence that the implant material you use provides both performance and value. The problem is there are a range of implant materials available that may create uncertainty regarding which is the most suitable to meet the expectations of your patients. We understand that corrosion, strength, wear and metal composition can all impact implant survivorship and quality of life for the patient.9,10 You need an implant material that can address these concerns through material science.4-8,11-19 OXINIUM◊ Technology THE MOMENT F CHANGE Does your knee Exclusive to Smith+Nephew, OXINIUM◊ Technology is an implant have award-winning,18 advanced implant material available for hip and knee arthroplasty. OXINIUM? With more than 20 years of clinical experience across 120 countries, OXINIUM Technology brings unrivalled material properties to a portfolio which contains best-in-class implant designs.11,14,15,19,20 OXINIUM Technology has shown strong clinical and health economic outcomes,delivering value for patients, payers and providers. 4,8,21,22 Minimize wear, corrosion and nickel/cobalt/chromium with OXINIUM Technology15,20,26 What is OXINIUM◊ Oxidized Zirconium? • An OXINIUM implant is composed of an award-winning18 oxidized zirconium (OxZr) alloy. The original metal is transformed through heating in air at over 500°C to create a 5 μm thick ceramicised oxide.11 Oxidation process • The unique manufacturing process means that, in contrast to other materials used in TJA, the ceramicised metal is not an externally applied coating. The result is a truly uniform surface transformation that provides the implant with the durability of metal, the wear of a ceramic bearing, and fretting/corrosion resistance that is better than both.11-13 • Combined with Smith+Nephew’s implant designs, OXINIUM Technology provides unique material properties to support excellent clinical and economic outcomes for patients.21,23,24 Dig deeper into the value that OXINIUM can provide Unrivalled Established material economic science11-15,19 benefits 21,25 Proven clinical Ideal for performance8,24 revisions26,27,33  Unrivalled material science 45 million is the number of simulated wear cycles tested in knee simulators without any measurable loss in oxide thickness – 9 times the industry standard which is estimated to be 30 years of use*15 2x the surface hardness of cobalt chrome, contributing to wear performance 12 Mean (+/- Std. Dev.) oxide thickness of the OXINIUM femoral components during laboratory wear testing15 4900x more abrasion resistant than cobalt chrome after 10M cycles of pin-on-disc lab testing using bone cement28 Comparison of metal content between OXINIUM◊ alloys and CoCr alloys26,29 160x smoother than a cobalt chrome surface following 10M cycles of pin-on-disc testing 28 Virtually zero levels of nickel, cobalt and chrome, 26,29 common metal sensitizers detected in 10-15% of the population 34 OXINIUM◊ may also have a reduced impact on the inflammatory response as demonstrated by lower pro-inflammatory cytokine expression in cells exposed to OXINIUM versus CoCrMo and Ti alloy†19 Unrivalled material science addresses your concerns regarding wear, strength and virtually undetectable nickel, cobalt and chrome – Why wouldn’t you have OXINIUM? *The LEGION◊ Primary CR Knee System completed 45 million cycles of in vitro simulated wear testing, which is an estimate of 30 years of activity. Other LEGION VERILAST Primary Knee Systems underwent similar lab testing comparable to industry standards. The results of in vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance. Also, a reduction in total polyethylene wear volume or wear rate alone may not result in improved clinical outcomes as wear particle size and morphology are also critical factors in the evaluation of the potential for wear mediated osteolysis and associated aseptic implant loosening. Particle size and morphology were not *All metal implants contain residual levels of metal elements. evaluated as part of the testing. May contain<0.01% wt. †The results of in vitro cytokine expression analyses have not been proven to quantitatively predict clinical cytokine expression.  3B 5B 7B 10B St Longer-term evidence Orthopaedic D 13A* GENESIS II 3A* Stronger evidence Total Knee System Proven clinical performance 3A CR OXINIUM Dished PE Insert and Biconvex Patella 13A* 5A* 7A* 3B 13 A* Longer-term e GENESIS◊ II JOURNEY UNI LEGION Total Knee System Knee System Total Knee System Multiple studies demonstrate excellent 10 year survivorship GENESIS II Knee ODEP ratings 32 CR OXINIUM OXINIUM PS OXINIUM Dished PE Insert and Biconvex Patella JOURNEY UNI tibia, JOURNEY UNI Insert and Total Knee System GENESIS II PS High Flex PE Insert and • 95.4% (n=44) in patients <50 years old§30 no patella. GENESIS II Round and oval patella. CR OXINIUM Dished PE Insert and Biconv • 97.1% (100% survivorship for aseptic loosening; n=303)¶31 13A* 5A*A 15 75A* 13 A* A* 7A*5A* 7A* • 97.8% (revision aseptic loosening; n=98) ¶8 GENESIS◊ II JOURNEY GENESIS IIUNI LEGION GENESIS JOURNEY ◊ II II BCS ◊ LEGION JOURNEY ◊ UNI LEGION Total Knee System Knee Total System Knee System Total KneeKnee Total OXINIUM System System TotalKnee KneeSystem System Total Knee System CR OXINIUM OXINIUM PS OXINIUM PS OXINIUM CRII OXINIUM JOURNEY BCS CR OXINIUM OXINIUM PS OXINIUM Dished PE Insert and Biconvex Patella JOURNEY UNI IItibia, JOURNEY UNI Insert II PS and OXINIUM with PE Dished JOURNEY Insert tibia, and JOURNEY Biconvex II with GENESIS JOURNEY II Baseplate, UNI tibia,GENESIS JOURNEY II PS UNI Insert and with GENESIS Baseplate, GENESIS GENESIS II PS High Flex PE Insert and Patella GENESIS II PS High Flex PE no PE patella. High Flex Insert & GENESIS II Round XLPE Insert and JOURNEY Resurfacing Patella. PE Highno Flex Insert & GENESIS II Round patella. GENESIS II Round and oval patella. GENESIS II Round and oval A*/A Independent assessment by the Orthopaedic Data Evaluation Panel (ODEP) and Oval Resurfacing Patella and Oval Resurfacing Patella Latest ODEP ratings can be found at www.odep.org.uk (last accessed on 24th Aug 2020). ◊ 15Atop levels of survivorship shows that OXINIUM knee implants perform at or above 5A*13 up A* 7A*15 5A*A 7 5A* 13 A* A* 7 5A* A* to 15 years post-implantation.32 GENESIS II JOURNEY GENESIS ◊ II BCS ◊ II LEGION ◊ JOURNEY GENESIS II UNI LEGION ◊◊ II BCS JOURNEY LEGION◊ GENESIS II JOURNEY UNI Total Knee System OXINIUM Total Knee System TotalTotal KneeKnee Knee System System System Total Knee System OXINIUM Total Knee System Total Knee System Knee System PS OXINIUM CRII BCS JOURNEY OXINIUM CR OXINIUM OXINIUM PS OXINIUM PS OXINIUM JOURNEY II BCS CR OXINIUM with GENESIS II Baseplate, GENESIS II PS OXINIUM with JOURNEY Dished tibia, PE Insert and JOURNEY Biconvex II Patella with GENESIS JOURNEY with II Baseplate, GENESIS GENESIS UNIIItibia, JOURNEY Baseplate, II PS UNI Insert GENESIS II PS and CR OXINIUM OXINIUM with JOURNEY tibia, JOURNEY II OXINIUM with GENESIS II Baseplate, G XLPE Insert and JOURNEY Resurfacing Patella. GENESISPEIIInsert PS High Flex PE Insert and JOURNEY UNI tibia, PE High Flex Insert & GENESIS II Round PE HighPE Flex no Insert Flex&Insert patella. High GENESIS II RoundII Round & GENESIS Dished XLPE Insert and Biconvex and JOURNEY Patella Resurfacing GENESIS II Round and oval patella. Patella. PE High Flex Insert &JOURN GENES 2X Lower In one analysis of registry data, the use of OXINIUM Technology and Oval Resurfacing Patella and Oval Resurfacing and Patella Patella Oval Resurfacing no patella. and Oval Resurfacing Patell Latest ODEP ratings can be found at www.odep.org.uk (last accessed on 24th Aug 2020). Latest ODEP ratings can be found at www.odep.org.uk (last accessed on 24th Aug 2020). resulted in a revision rate that was two times lower than cobalt chrome in patients 15A 7A*A younger than 65 years old,23 typically a challenging population for implant survivorship.7 13A*5A* 5A*15 7A* 5A* GENESIS II JOURNEY◊ II BCS LEGION◊ GENESIS◊ II GENESIS JOURNEY UNIII System JOURNEY◊ II BCS LEGION Total Knee System OXINIUM Total Knee TotalJOURNEY Knee System Total KneeCR System Knee System TotalOXINIUM Knee System Latest Hip and PS OXINIUM with GENESIS II Baseplate, GENESIS II PS PE High Flex Insert & GENESIS II Round CR OXINIUM XLPE Dished PE II BCS Insert Insert andand JOURNEY Biconvex Patella with OXINIUM PS OXINIUM OXINIUM with JOURNEY tibia, JOURNEY II OXINIUM GENESIS II Baseplate, GENESIS II PS Resurfacing Patella.JOURNEY with PE GENESIS High UNI tibia, II Baseplate, Flex JOURNEY Insert UNIGENESIS & GENESIS II PS II Round Insert and PS OXINIUM JOURNEY II BCS OXINIUM with JOURNEY tib Knee ODEP ratings GENESIS II PSInsert High Flex and PE Insert a OXINIUM Technology delivers proven clinical PE High and OvalFlex Insert & GENESIS Resurfacing Patella II Round XLPE JOURNEY and Oval Resurfacing Patella no patella. and Oval Resurfacing Patella GENESIS II Round and oval patella. Latest ODEP ratings can be found at www.odep.org.uk (last accessed on 24th Aug 2020). performance in patients across a range of age and Latest ODEP ratings can be found at www.odep.org.uk (last accessed on 24th Au Orthopaedic Data Evaluation Panel (ODEP) Rating Chart 15 A 3A* 5A* 7A* 10A* 5A* 13 15A* 7A* activity expectations emphasizing the importance A* Stronger evidence 3A II 5A 7A 10AJOURNEY 15A 13A ◊ II BCS of having OXINIUM. GENESIS Total Knee System OXINIUM LEGION◊ Total Knee System 3B PS OXINIUM 5B 7B 10BJOURNEY 13II BCS B 15B CR OXINIUM with GENESIS II Baseplate, GENESIS II PS OXINIUM with JOURNEY tibia, JOURNEY II with GENESIS II Baseplate, GENESIS PE High Flex Insert & GENESIS II Round XLPE Insert and JOURNEY Resurfacing Patella. PE High Flex Insert & GENESIS II Rou Longer-term evidence and Oval Resurfacing Patella and Oval Resurfacing Patella Latest ODEP ratings can be found at www.odep.org.uk (last accessed on 24th Aug 2020). § using OXINIUM PROFIX implants, ¶ using OXINIUM GENESIS II implants 13A*  Established economic benefit Length of stay Discharge to home Discharge to SNF JOURNEY◊ II BCS implants JOURNEY II BCS patients were 35% more likely JOURNEY II BCS patients were 41% less likely with OXINIUM◊ significantly to be discharged to home/home health care to be discharged to a Skilled Nursing Facility reduced hospital stays (p<0.0001)21 versus other total knee systems (p<0.0001)21 versus other total knee systems (p<0.0001)21 26% more likely versus TriathlonTM Knee System 28% less likely versus TriathlonTM Knee System (p=0.003)25 (p=0.0003)25 Readmission Patients receiving JOURNEY II BCS with OXINIUM were 51% less likely to be readmitted within 30 days compared to other TKA systems (p=0.0037)21 27% less likely to be readmitted within 1-year compared to TriathlonTM Knee System (p=0.0264)25 $1,690 OXINIUM powered implant designs, like The average total hospital cost savings comparing JOURNEY JOURNEY II BCS, allow the patient to II BCS, powered by OXINIUM, potentially get home faster, return to life compared to all other TKA with a lower chance of complications and systems using US CMS/ Medicare data, a significant save money across the episode of care - saving including the cost of Can you afford not to have OXINIUM? implant (p<0.0001)21  Ideal for revisions 60% The proportion of patients with poorly performing joint replacements who show reaction to nickel, cobalt and/or chromium34 Virtually zero levels of nickel, cobalt and chrome 26,29 and chromium in OXINIUM Oxidized Zirconium OXINIUM◊ Technology in knee applications has been shown to minimize metallic artifacts with magnetic resonance imaging to confirm placement during follow-up compared to cobalt chrome33 Lower 13-year revision rate of LEGION Revision, powered by OXINIUM, ◊ versus the class average for revision TKA in the National Joint Registry for England, Wales and Northern Ireland‡27 (11.9% vs. 12.7%) LEGION Revision, powered by OXINIUM, demonstrates significantly fewer re-revisions due to aseptic loosening of the femur compared to the class average (p=0.01)‡27 The same unrivalled material science that makes OXINIUM Technology great for primary procedures can provide benefit to revisions as well – Why wouldn’t you have OXINIUM? ‡ We thank the patients and staff of all the hospitals in England, Wales and Northern Ireland who have contributed data to the National Joint Registry. We are grateful to the Healthcare Quality Improvement Partnership (HQIP), the NJR Steering Committee and staff at the NJR Centre for facilitating this work. The views expressed represent those of Smith+Nephew and do not necessarily reflect those of the National Joint Registry Steering Committee or the Health Quality Improvement Partnership (HQIP) who do not vouch for how the information is presented. The data used for this analysis was obtained from the National Joint Registry (“NJR”), part of the Healthcare Quality Improvement Partnership (“HQIP”). HQIP, the NJR and/or its contractor, Northgate Public Services (UK) Limited (“NPS”) take no responsibility (except as prohibited by law) for the accuracy, currency, reliability and correctness of any data used or referred to in this report, nor for the accuracy, currency, reliability and correctness of links or references to other information sources and disclaims all warranties in relation to such data, links and references to the maximum extent permitted by legislation including any duty of care to third party readers of the data analysis. Smith & Nephew, Inc. www.smith-nephew.com ◊ Trademark of Smith+Nephew 1450 Brooks Road All Trademarks acknowledged Memphis, Tennessee 38116 ©2021 Smith & Nephew, Inc. USA 30007 V1 08/21 References 1. Klug A, Gramlich Y, Rudert M, et al. The projected volume of primary and revision total knee arthroplasty will place an immense burden on future health care systems over the next 30 years. Knee Surgery, Sports Traumatology, Arthroscopy. 2020;15:1-12. 2. Sloan M, Premkumar A, Sheth NP. Projected Volume of Primary Total Joint Arthroplasty in the U.S., 2014 to 2030. J Bone Joint Surg Am. 2018;100:1455-1460. 3. Ackerman IN, Bohensky MA, Zomer E, et al. The projected burden of primary total knee and hip replacement for osteoarthritis in Australia to the year 2030. BMC Musculoskeletal Disorders. 2019;23(1):90. 4. Davis ET, Pagkalos J, Kopjar B. Bearing surface and survival of cementless and hybrid total hip arthroplasty in the National Joint Registry of England, Wales, Northern Ireland and the Isle of Man. Journal of Bone Joint Surgery. 2020;5(2):pe0075. 5. Peters RM, Van Steenbergen LN, Stevens M, et al. The effect of bearing type on the outcome of total hip arthroplasty. Acta Orthopaedica. 2018; 89(2):163-169. 6. Atrey A, Ancarani C, Fitch D, Bordini B. Impact of bearing couple on long-term component survivorship for primary cementless total hip replacement in a large arthroplasty registry. Poster presented at: Canadian Orthopedic Association; June 20–23, 2018; Victoria, British Columbia, Canada. 7. Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) Hip, Knee & Shoulder Arthroplasty: 2020 Annual Report. 8. Innocenti M, Matassi F, Carulli C, Nistri L, Civinini C. Oxidized zirconium femoral component for TKA: A follow-up note of a previous report at a minimum of 10 years. The Knee. 2014;21:858– 861. 9. Fernandez-Fernandez R, Cruz-Pardos A, Garcia-Rey E. Revision Total Hip Arthroplasty: Epidemiology and Causes. In: Rodríguez-Merchán E. Revision Total Joint Arthoplasty. Springer, 2020. 10. Lewis PL, Robertsson O, Graves SE, et al. Variation and trends in reasons for knee replacement revision: a multi-registry study of revision burden. Acta Orthopaedica. 2020. DOI: 10.1080/17453674.2020.1853340. 11. Hunter G, Dickinson J, Herb B, et al. Creation of oxidized zirconium orthopaedic implants. Journal of ASTM International. 2005;2:1-14. 12. Long M, Riester L, Hunter G. Nano-hardness Measurements of Oxidized Zr-2.5Nb and Various Orthopaedic Materials. Abstract presented at: 24th Annual Meeting of the Society for Biomaterials. April 22-26, 1998, San Diego, California. 13. Parikh A, Hill P, Hines G, Pawar V. Wear of conventional and highly crosslinked polyethylene liners during simulated fast walking/jogging. Poster presented at: 55th Annual Meeting of the Orthopaedic Research Society, 2009. Poster no. 2340. 14. Parikh A, Hill P, Pawar V, Sprague J. Long-term Simulator Wear Performance of an Advanced Bearing Technology for THA. Poster presented at: 2013 Annual Meeting of the Orthopaedic Research Society. Poster no. 1028. 15. Papannagari R, Hines G, Sprague J, Morrison M. Long-term wear performance of an advanced bearing technology for TKA. Poster presented at: 2011 Annual Meeting of the Orthopaedic Research Society. Poster no. 1141. 16. Aldinger P, Williams T, Woodard E. Accelerated Fretting Corrosion Testing of Zirconia Toughened Alumina Composite Ceramic and a New Composition of Ceramicised Metal Femoral Heads. Poster presented at: 2017 Annual Meeting of the Orthopaedic Research Society. Poster no. 1037. 17. Smith+Nephew 2016. OR-16-127. 18. 2005 ASM International Engineering Materials Achievement Award. 19. Dalal A, Pawar V, McAllister K, Weaver C, Hallab NJ. Orthopedic implant cobalt-alloy particles produce greater toxicity and inflammatory cytokines than titanium alloy and zirconium alloy-based particles in vitro, in human osteoblasts, fibroblasts, and macrophages. J Biomed Mater Res Part A. 2012;100A:2147-2158. 20. Pawar V, Jones B, Sprague J, Salehi A, Hunter G. Acidic Fretting Tests of Oxidized Zr-2.5Nb, CoCr and SS Femoral Heads. Paper presented at: Materials & Processes for Medical Devices Conference, ASMI, St. Paul, Minnesota, 2004. 21. Mayman DJ, Patel AR, Carroll KM. Hospital related clinical and economic outcomes of a bicruciate knee system in total knee arthroplasty patients. Poster presented at: ISPOR Symposium; May 19-23, 2018; Baltimore, Maryland, USA. 22. Patrick C, Delhougne G, Patel A. Retrospective Analysis of Oxidized Zirconium Bearing Surface in Hip Replacement 90-Day Episode Claims. ISPOR EU Poster, 2019. 23. Civinini R, Carulli C, Matassi F, et al. The Survival of Total Knee Arthroplasty: Current Data from Registries on Tribology. HSS Journal. 2017;13:28-31. 24. Civinini R, Matassi F, Carulli C, et al. Clinical Results of Oxidized Zirconium Femoral Component in TKA. A Review of Long-Term Survival. HSS Journal. 2017;13:32-34. 25. Patel AR, Delhougne G. Hospital related clinical and economic outcomes of two premium knee system in total knee arthroplasty patients. Poster presented at: ISPOR Symposium; May 22, 2019; New Orleans, LA, USA. 26. ASTM International Standard Specification for Wrought Zirconium-2.5 Niobium Alloy for Surgical Implant Applications (UNS R60901) Designation: F 2384 – 10. 27. National Joint Registry for England, Wales and Northern Ireland: LEGION revision OXINIUM (with revision tibial) implant summary report. 18 May 2022. Available at: https://bit.ly/3w8TEl9. 28. Hunter G, Long M. Abrasive wear of oxidized Zr-2. 5 Nb, CoCrMo, and Ti-6 Al-4 V against bone cement. Abstract presented at: Sixth World Biomaterials Congress, 2000. 29. ASTM International Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075): Designation: F 75 – 12. 30. Glover AW, Santini AJA, Davidson JS, Pope JA. Mid- to long-term survivorship of oxidised zirconium total knee replacements performed in patients under 50 years of age. The Knee. 2018;25:617-622. 31. Ahmed I, Salmon LJ, Waller A, et al. Total knee arthroplasty with an oxidized zirconium femoral component: Ten Year Survivorship Analysis. Bone Joint J. 2016;98-B:58–64. 32. The Orthopaedic Data Evaluation Panel (ODEP). www.odep.org.uk. Accessed April 12th, 2021. 33. Lee KY, Slavinsky JP, Ries MD, Blumenkrantz G, Majumdar S. Magnetic Resonance Imaging of In Vivo Kinematics After Total Knee Arthroplasty. Journal of Resonance Imaging. 2005;21:172–178. 34. Hallab N, Merritt K, Jacobs JJ. Metal Sensitivity in Patients with Orthopaedic Implants. JBJS. 2001;83(3):428-436.  Surgical Technique LEGION TKS Distal Cut First Preparation with Universal Instruments LEGION™ Total Knee System Distal Cut First Preparation Primary Total Knee Arthroplasty Contents Introduction................................................................1 Technique highlights..................................................2 Preoperative planning................................................6 Instrument assembly..................................................7 DCF femoral resection Intramedullary alignment.....................................9 Distal resection....................................................10 Sizing guide procedure.......................................11 A/P resection.......................................................15 Extramedullary (EM) tibial resection EM tibial preparation............................................17 Tibial resection.....................................................19 Tibial sizing..........................................................21 Component trialing..............................................23 Posterior stabilized resection.....................................24 Component implantation............................................29 Options/Alternatives Patella preparation...............................................33 Intramedullary (IM) tibial preparation...................38 Appendix A Implant size interchangeability............................43 Catalog Information....................................................44 Implant Compatibilities...............................................50 Nota Bene The following technique is for informational and educational purposes only. It is not intended to serve as medical advice. It is the responsibility of treating physicians to determine and utilize the appropriate products and techniques according to their own clinical judgment for each of their patients. For more information on the product, including its indications for use, contraindications, and product safety information, please refer to the product’s label and the Instructions for Use (IFU). Additional LEGION Total Knee System surgical technique brochures are available for the other LEGION components and sets. LEGION instruments listed within reflect examples in the LEGION Universal Instrument Set. Introduction The LEGION™ Total Knee System has been designed to offer the orthopaedic surgeon solutions to address intraoperative situations. Implant function is directly related to accurate surgical technique. The instrumentation can be used in minimally invasive or standard exposures. 1 Technique highlights Distal femoral resection Use the 9.5mm drill to open up the femoral canal and slide the valgus alignment assembly until at least one side contacts the distal femur. After the assembly is placed in neutral rotation, impact the floating spikes into the distal femur and secure the distal block with pins. Remove the IM rod, unlock the lever on the valgus alignment guide and remove the valgus alignment assembly using the universal extractor. Resect the distal femur. Position the sizing guide flush against the distal femur, while ensuring that the posterior paddles are contacting the underside of both posterior condyles. To set rotation Pin through lateral pivot pinhole, located on the lower lateral corner of the sizing guide. Adjust external rotation of the sizing guide by turning the rotational adjustment knob clockwise (0-6°). Fixed posterior referencing Ensure the sizing guide is set in the ‘0’ position. Drill and insert two pins through the locator holes of the sizing guide. Determine the size of the component by the graduations on the stylus. If the femur is in-between two sizes, choose the larger size. 2 Adjustable anterior referencing Position the sizing guide stylus so that it contacts the lateral ridge of the anterior cortex and determine the size from the graduations on the shaft of the stylus. If the indicated size is in-between two sizes, turn the upper hex screw clockwise to the next lower size for anterior referencing or turn the upper hex screw counterclockwise to the next larger size. To lock in position, tighten the locking hex screw. Drill to mark the locator holes for the A/P cutting block. Place the correctly sized A/P cutting block on the distal femur and make anterior, posterior and chamfer cuts. 3 Tibial resection Place the extramedullary tibial guide with the non-spiked (shown) or spiked rod and place on tibia. Align guide over medial third of the tibial tubercle and parallel to the tibia. Attach the tibial stylus to the tibial cutting block and lower the cutting block until the stylus touches the low point on the least affected side of the tibia. Once the resection level is determined, insert pins to secure and remove alignment assembly. Resect the proximal tibia. Size the tibia. Posterior stabilized housing resection Pin trial through anterior flange. Select the Housing Resection Collet matching the femoral trial size (either 1-2 or 3-8). Ream through the collet in the anterior position until the depth stop makes contact. Remove the reamer and move the collet to the posterior position. Ream through the collet once more until contact is made. Impact the Housing Box Chisel anteriorly and then posteriorly through the Housing Resection Collet to square the corners of the PS box resection. Select the appropriate size femoral trial cam module, insert the arms of the cam module into the anterior aspect of the femoral trial box and rotate posteriorly. 4 Final preparation After trial range of motion and alignment checks, select the appropriate trial fin punch and punch through the trial. Place the femoral implant on the femur and use the femoral impactor to fully seat the implant. Apply tibial baseplate cover to protect tibial baseplate. Seat the tibial implant with the tibial impactor. Insert the articular insert by placing the insert assembly tool into the center notch of the anterior lock detail (handle up) and engage the two tabs of the tool into the two recesses on the anterior periphery of the insert. Squeeze the tool handle until the insert is fully seated within the tibial component. 5 Preoperative planning Determine the angle between the anatomical M V M A and the mechanical axes. This measurement 6º will be used intraoperatively to select the appropriate valgus angle so that correct limb 3º 3º alignment is restored. (Beware of misleading angles in knees with a flexion contracture or rotated lower extremities.) Tip Many surgeons prefer to simply select a standard angle for the distal femoral cut (ie, 5º, 6º or 7º) based on the patient and surgical experience. Recommended sawblades T 1.27 Sawblade (for standard blocks) Cutting thickness and blade thickness should be 0.050" or 1.27mm. 3º 3º 1.35 Sawblade (for MIS blocks) Cutting thickness and blade thickness should be 1.35mm. M = Mechanical Axis A = Anatomical Axis T = Transverse Axis V = Vertical Axis 6  Instrument assembly IM femoral assembly 1 Attach the selected valgus angle bushing (5°, 6° or 7°) to the valgus alignment guide. Check the bushing position to make sure that ‘left’ is facing anteriorly when operating on a left knee and ‘right’ is facing anteriorly when operating on a right knee. 2 Attach a modular T-handle to the IM rod and insert through the alignment assembly (Figure 1). 3 Assemble the distal femoral cutting block onto the valgus alignment guide. Positioning the block at the ‘primary’ resection level will ensure the cut will equal the distal thickness of the femoral prosthesis. Lock by pressing the lever in a horizontal position toward the medial side. Figure 1 Extramedullary tibial alignment guide Insert the ankle clamp into the distal end of the alignment tube and thread the locking pin into the ankle clamp (Figure 2). Gold Knob After the ankle clamp is moved into the proper position, lock into place with the gold knob. Choose the correct left or right tibial cutting block. Select the spiked or non-spiked fixation rod. Figure 2 Valgus Bushing Alignment Guide T-handle IM Rod Distal Cutting Ankle Clamp 5° 71440014 71441144 71110080 Long 71512040 Block 71440444 6° 71440016 Short 71512035 71441147 7° 71440018 Alignment Tube 71440448 7 Instrument assembly Central Knob Non-spiked fixation rod Place the appropriate left or right tibial cutting block on top of the disc on the non-spiked fixation rod (Figure 3). Tighten the central knob to lock the block into position. Introduce the rod into the extramedullary assembly and adjust and lock the cam in the assembly. Spiked fixation rod Place the spiked fixation rod through the hole in the tibial cutting guide; adjust the block and tighten the central knob to lock the block into position. Locking Cam Introduce the spiked fixation rod into the proximal end of the alignment assembly and adjust and Figure 4 lock the cam on the assembly (Figure 4). Figure 3 Tibial Cutting Block Non-spiked Spiked Fixation Rod Left 71441136 Fixation Rod 71440198 Right 71441137 71440446 8  DCF Femoral resection Intramedullary alignment 1 Open the femoral canal with a 9.5mm intramedullary drill (Figure 5). Tip If desired, the distal femoral cutting block may be set to resect an additional +2, +5 or +7mm of bone. Figure 5 2 Slide the intramedullary rod of the assembly into the femoral canal until the alignment guide Locked contacts the distal femur (Figure 6). Tip There may be times when only one side of the guide will touch bone. 3 Orient rotation of the assembly neutral to the posterior condyles (Figure 7) and impact one or both of the floating spikes into the distal femur. Instrument assembly Figure 6 Figure 7 Valgus Bushing Alignment Guide T-handle IM Rod Distal Cutting IM Drill 5° 71440014 71441144 71110080 Long 71512040 Block 74012111 6° 71440016 Short 71512035 71441147 7° 71440018 9  Distal resection 1 Using non-headed pins, pin the distal femoral cutting block to the anterior femur using the holes marked ‘0’. Once adequate distal femoral resection is noted, an additional headed or non-headed pin should be placed obliquely to provide additional stability (Figure 8). 2 Unlock the lever on the valgus alignment guide, remove the intramedullary rod and the valgus alignment assembly using the universal extractor (Figure 9). Only the distal femoral cutting block should remain on the femur. Figure 8 3 Resect the distal femur (Figure 10) then remove the distal femoral cutting block. Unlocked Tip If the distal femoral resection is not adequate, remove the oblique pin, and reposition the block through the pin holes marked +2 or +4mm for the desired level of resection and re-insert the oblique pin. Figure 9 Figure 10 Valgus Bushing Alignment Guide Universal Extractor IM Rod Distal Cutting 5° 71440014 71441144 71440366 Long 71512040 Block 6° 71440016 Short 71512035 71441147 7° 71440018 10 Instrument assembly Sizing guide procedure A/P Axis The sizing guide allows for external rotation to be set from 0-6º based on surgeon preference and patient anatomy. Rotational alignment may be checked by aligning the A/P axis with the pointer on the sizing guide or by ensuring that the laser marked lines on the face of the Epicondylar Axis guide are parallel with the epicondylar axis. The rotational adjustment knob on the lower portion Rotational Adjustment Knob of the guide is turned to dial in rotation (Figure 11). Figure 11 The guide can be used for fixed posterior referencing or can be adjusted anteriorly or posteriorly for fine tuning. When in-between sizes, the surgeon can choose to adjust sizing up to 4mm anteriorly, thereby taking up to an additional 4mm off the posterior condyles, or up to 2mm posteriorly, taking up to an additional 2mm off of the anterior cortex. If the anterior surface of the guide is in-between two sizes when it is at the zero position, the upper hex screw can be rotated to shift the Upper Hex Screw anterior face of the sizing guide up to the next smaller size or down to the next larger size on Locking Hex Screw the stylus. As a result, the locator holes for the A/P cutting block are shifted either anteriorly or posteriorly to align with the next implant size (Figure 12). Tip The gap between the top of the sizing Figure 12 Locator Holes guide and the stylus graduation line indicates how much bone will be removed from either the anterior cortex or posterior condyles by choosing the next larger size (Figure 13). Figure 13 Sizing Guide Sizing Stylus Hex Screwdriver Left 71440007 71441140 115035 Right 71440008 11  Sizing guide procedure: rotation 1 Flex the knee, approximately 90º so the posterior condyles are accessible. 2 Choose appropriate sizing guide, ‘Left’ for a left knee and ‘Right’ for a right knee. 3 Position the femoral sizing guide flush against the distal femur, while ensuring the posterior Lateral Pivot Pin paddles are contacting the underside of both posterior condyles. Once correct position of Figure 14 sizing guide is established, place a pin through lateral pivot pinhole located in the posterior/ lateral corner on the face of the sizing guide (Figure 14). A/P Axis 4 Adjust the external rotation of the sizing guide to be aligned anatomically with the epicondylar and/or A/P axis. This can be achieved by turning the rotational adjustment knob (0-6º) using a hex screwdriver (Figure 15). Epicondylar Axis 5 Once rotation is set, sizing can be established either by fixed posterior referencing or adjustable referencing. Rotational Adjustment Knob Figure 15 Sizing Guide Sizing Stylus Hex Screwdriver Left 71440007 71441140 115035 Right 71440008 12  Sizing guide procedure: fixed posterior referencing 1 Ensure that the anterior surface of the sizing guide is set in the ‘0’ position. 2 Drill and insert two pins through the locator holes of the sizing guide to secure the guide. 3 Position the sizing guide stylus so that it contacts Figure 16 the lateral ridge of the anterior femoral cortex (highest point on the anterior cortex of the femur) (Figure 16). 4 Determine the size of the component from the graduations on the shaft of the stylus. 5 If the femur is between sizes, chose the larger size. 6 Remove the pins and the sizing guide. Sizing Guide Sizing Stylus Hex Screwdriver Left 71440007 71441140 115035 Right 71440008 13  Sizing guide procedure: adjustable anterior referencing 1 Ensure that the anterior surface of the sizing guide is set in the ‘0’ position. Upper Hex Screw 2 Drill and insert two pins through the oblique holes of the sizing guide to secure the guide. Locking Hex Screw 3 Position the sizing guide stylus so that it contacts the lateral ridge of the anterior femoral Locator Holes cortex (highest point on the anterior cortex of the femur) (Figure 17). Figure 17 4 Determine the size of the component from the graduations on the shaft of the stylus. 5 If the indicated size is in-between sizes, you can turn the upper hex screw to shift the anterior surface up to an additional 4mm to the next smaller size or down an additional 2mm to the next larger size (Figures 18a and b). Once the appropriate size is selected, turn the locking hex screw to lock the anterior surface and locator holes into position (Figure 17). 6 Drill the locator holes to set the position for the cutting block. Anterior Reference Shift of 4mm Figure 18a 7 Remove the pins and sizing guide. Posterior Reference Shift of 2mm Figure 18b Sizing Guide Sizing Stylus Hex Screwdriver Left 71440007 71441140 115035 Right 71440008 14 Instrument assembly A/P resection 1 Position the fixed spikes on the A/P cutting block into the predrilled holes. Tip It is not necessary that the block be centered M/L on the distal femur. 2 Ensure that the cutting block is flush with the Figure 19 resected distal femur. Several holes in the A/P block allow fixation of the block. Place one pin centrally through one of the middle holes just medial or lateral to the quick-connect attachment. For additional stability, a headed pin may be placed through the holes on the medial or lateral side of the block (Figure 19). 3 Complete the anterior, posterior and chamfer Figure 20 cuts (Figures 20-23). The block is designed to allow for angling of the sawblade during the cuts. Tip To maintain block stability, the anterior chamfer cut should be completed last. Figure 21 Figure 22 Figure 23 A/P Cutting Block sz 5 71441153 15  Downsizing the femoral component 1 Attach the downsizing drill guide to the cut femur, placing the spikes on the back of the plate into the same location holes used for the A/P cutting block (Figure 24). 2 Drill new location holes through the downsizing drill guide (shifted 2mm anterior). 3 Place the smaller A/P cutting block into the new location holes. Redo the posterior, anterior and chamfer cuts. Tip It is useful to mark the original pin track Figure 24 holes with a marking pen in order to properly identify the new holes. Downsizing Drill Guide 71440860 16  Extramedullary (EM) tibial resection EM tibial preparation When using the extramedullary tibial alignment, the surgeon may use a non-spiked or spiked fixation rod. Non-spiked fixation 1 Place the arms of the extramedullary alignment clamp around the ankle, and adjust the distal M/L slide directly over the middle of the tibiotalar joint, which is also approximated by the second ray of the foot proximal to the malleoli (Figure 25). The cutting block on the proximal end of the assembly should be proximal to the tibial tubercle (Figure 26). 2 Assess rotation of the alignment guide and slope Figure 25 Figure 26 of the cutting plane. The goal is to align the extramedullary alignment assembly rotationally so that it aligns over the medial third of the tibial tubercle and over the second toe (Figure 27). 3 Rotational alignment is critical due to the 3° posterior sloped cut. The slope can be adjusted according to the patient’s anatomy (Figure 28). Note 3-5° of slope is built into the articular insert (depending on which insert is chosen) and 3° of slope is built into the tibial cutting block. A neutral or slightly sloped alignment should usually be chosen. Tip Neutral or minimally sloped alignment may be achieved by palpating the fibula followed by aligning the alignment guide parallel to the fibula. Tibial bowing and soft tissue bulk may make external tibial referencing unreliable. Figure 27 Figure 28 Ankle Clamp Alignment Tube Tibial Cutting Block Non-spiked 71440444 71440448 Left 71441136 Fixation Rod Right 71441137 71440446 17  Spiked fixation 1 Place the arms of the extramedullary alignment clamp around the ankle, and adjust the distal M/L slide directly over the middle of the tibiotalar joint, which is also approximated by the second ray of the foot proximal to the malleoli (Figure 29). The cutting block on the proximal end of the assembly should be proximal to the tibial Figure 30 tubercle (Figure 30). 2 Impact the longer spike of the spiked fixation rod into the proximal tibia (Figure 31). Figure 29 3 Assess rotation of the alignment guide and slope of the cutting plane. The goal is to align the extramedullary alignment assembly rotationally so that it aligns over the medial third of the tibial tubercle and over the second toe (Figure 32). 4 Rotational alignment is critical due to the 3° posterior sloped cut. The slope can be adjusted according to the patient’s anatomy Figure 31 (Figure 33). Impact the second spike to secure the assembly (Figure 34). Note 3-5° of slope is built into the articular insert (depending on which insert is chosen) and 3° of slope is built into the tibial cutting block. A neutral or slightly sloped alignment should usually be chosen. Figure 32 Tip Neutral or minimally sloped alignment may be achieved by palpating the fibula followed by aligning the alignment guide parallel to the fibula. Tibial bowing and soft tissue bulk may make external tibial referencing unreliable. Figure 33 Figure 34 Ankle Clamp Alignment Tube Tibial Cutting Block Spiked Fixation Rod 71440444 71440448 Left 71441136 71440198 Right 71441137 18  Tibial resection 1 Attach the tibial stylus to the tibial cutting block by inserting the stylus foot into the cutting slot. 2 Lower the cutting block until the stylus touches the low point on the least affected side of the tibia (Figure 35). The stylus can be adjusted for a 1-13mm tibial resection by twisting the knob on top of the stylus. If the affected side of the tibia is to be used as a reference, the stylus may be adjusted for a 1-9mm resection level. Figure 35 3 Pin the tibial cutting block to the tibia by inserting pins first through the central holes; then the oblique hole. Tip Pinning through the central holes marked 0mm with smooth pins will allow the block to be moved +2mm should additional resection be required (Figure 36). Tip A 9mm resection is recommended since 9mm of metal and plastic is the thinnest available component. Tip To do an extramedullary alignment check, Figure 36 place the extramedullary alignment rod through the tibial cutting block. 4 To remove the assembly: a For the assembly with spiked rod, release the cam at the top of the alignment tube and use the universal extractor to remove the spiked fixation rod (Figure 37) after loosening the thumbscrew. b The assembly with the non-spiked rod may be left in place or removed by loosening the thumbscrew and lowering the non-spiked rod to disengage from the tibial cutting block. Knob (unlocked) Figure 37 Tibial Stylus Alignment Rod Tibial Cutting Block 71441143 71441148 Left 71441136 Right 71441137 19 5 Cut the tibia by first directing the blade in the posterior direction and then laterally (Figure 38). Check Alignment and Balance 1 Assemble the Quick Connect Handle to the Flexion/Extension block. Attach desired thickness of Flexion/Extension Spacer onto the Figure 38 Flexion/Extension block. 2 Insert the Flexion/Extension block into the extension gap. Evaluate alignment, balance, and extension space (Figure 39) 3 Adjust the thickness of the spacer as needed to determine the extension space. Spacer Block 4 Remove the block and reassemble desired thickness of spacer for flexion gap evaluation. 5 With the knee flexed to 90 degrees, place the Flexion/Extension Block into the joint space. Figure 39 6 Apply a varus/valgus force and assess the medial and lateral compartment laxity levels of the flexion space. Then adjust the thickness of the spacer as needed to determine the flexion space. 7 When the flexion space is determined, compare the thickness selected relative to the extension space previously determined. Note: Remember any difference between the Extension and Flexion Gap Assessments as this will affect how the femoral implant is positioned in the steps ahead (e.g. 10mm Ext - 11mm Flex = -1mm Flex Imbalance). Universal Extractor Tibial Cutting Block Flexion/Extension Flexion/Extension Quick Connect 71440366 Left 71441136 Block Standard Spacers Handle Right 71441137 74018603 9mm 74018608 71440044 11mm 74018611 13mm 74018613 15mm 74018615 18mm 74018618 21mm 74018621 20  Tibial sizing Option A – stemless tibial trials 1 Attach a quick-connect handle to a stemless trial one size below the femoral component size and place on the cut tibia to assess coverage (Figure 40). As needed, additional sizes should be templated using the stemless trials. 2 Once the appropriate size is determined, pin the medial side of the selected stemless trial with a short headed pin. 3 Place a trial insert into the stemless tibial trial tray and perform a trial range of motion to allow the baseplate to center on the femoral trial. Quick-connect Handle (As a secondary check, the surgeon may pass the alignment rod through the quick-connect handle to assess alignment) (Figure 41). Pin the Figure 40 lateral side of the trial. Tip After putting the knee through a trial range of motion, the surgeon should note the proper rotation of the trial tibial component on the proximal tibia and mark the tibia for future reference. Tip The center-line marks on the femoral and tibial trial components should line up. Drop Rod 4 Using the tibial fin/stem punch, rotational alignment may be set now or at the time of trial placement. Tip If the tibial bone is sclerotic, first drill for the stem using the 11mm tibial drill. Begin the fin Figure 41 slot with a burr or thin sawblade before using the fin punch to prevent tibial fracture. Quick-connect Stemless Trials Fin/Stem Punch 11mm Tibial Drill Handle Left sz 3-4 71449993 71440040 71440044 sz 4 71430167 Right sz 4 71430183 21  Option B – stemmed tibial trials (NOT AVAILABLE IN UNIVERSAL INSTRUMENT SETS) 1 Place a tibial drill guide one size below the femoral component size on the cut tibia to assess coverage. As needed, additional sizes should be templated (Figure 42). 2 Once the tibial drill guide has been centralized Figure 42 on the proximal tibia, pin the drill guide in place. Retract the gold collar on the drill guide handle and insert the 11mm tibial collet. 3 With the 11mm tibial collet in place, drill with the 11mm tibial drill (Figure 43) and punch with the 11mm tibial punch (Figure 44). 4 Remove the tibial drill guide. 5 Place the stemmed tibial trial into the prepared hole. Figure 43 6 Using the tibial fin punch, rotational alignment may be set now or at the time of trial placement. Tip After putting the knee through a trial range of motion, the surgeon should note the proper rotation of the trial tibial component on the proximal tibia and mark the tibia for future reference. Tip The center-line marks on the femoral and tibial trial components should line up. Figure 44 11mm Tibial Punch 11mm Tibial Drill Stem Trials Fin/Stem Punch 71440262 71440040 Left sz 3-4 71440266 sz 4 71430166 Right sz 4 71430182 22  Component trialing Femoral component trialing 1 Flex the knee to 90° and insert the femoral trial using the femoral trial impactor (Figure 45). 2 Perform a trial range of motion to assess patellar tracking. With cruciate-retaining knees, medial/ Figure 45 lateral placement of the femoral trial can be adjusted to optimize patellar tracking (Figure 46). 3 For cruciate-retaining femorals, prepare the femoral lug holes through the femoral trial with the femoral lug punch (Figure 47). Note: This step is also required for cemented posterior-stabilizing femorals using femoral lugs or Flex-Lok pegs. Figure 46 Note: It is recommended to leave the femoral trial on at this point to perform full component trialing. However, if desired, you may attach the end of the universal extractor to the femoral trial and remove the femoral trial (Figure 48). Lug Punch Figure 47 Extractor Figure 48 Femoral Trial Femoral Trial Lug Punch Universal Extractor Left Impactor 71440183 71440366 sz 5 71433345 71440009 Right sz 5 71433355 23  Posterior stabilized resection Femoral housing box resection 1 Pin the femoral trial through the anterior flange (Figure 49). 2 Choose the housing resection Collet matching the femoral trial size (either 1-2 or 3-8). Attach the Collet to the femoral trial by sliding the Housing Collet (anterior to posterior) into the slots on the distal face of the femoral trial and threading the two posts into the femoral trial. The Housing Collet should be secured in the anterior Figure 49 position first and then shifted to the posterior position and screwed (Figure 50). Housing Collet Figure 50 Femoral Trial Housing Collet Left Resection sz 5 71433345 sz 3-8 71434424 Right sz 5 71433355 24 3 Attach the Housing Reamer Dome and the PS Reamer Sleeve to the Patellar Reamer Shaft (Figure 51). Ream through the housing resection Collet in both the anterior and posterior positions until the depth stop contacts the Collet (Figure 52). 4 Impact the Housing Box Chisel through the Housing Resection Collet to square the corners of the housing. The Housing Box Chisel should be used anteriorly and then posteriorly to ensure that the full length of the box is Housing Reamer Dome prepared (Figure 53). Figure 51 Figure 52 Figure 53 Housing Reamer Housing Box Chisel Patellar Reamer Reamer Sleeve Dome 71440373 Shaft 71440464 71440145 71440324 25  Femoral trial cam module assembly 1 Select the appropriate sized femoral trial cam module (matching the femoral trial size selected). 2 Insert the arms of the femoral cam module into the anterior aspect of the femoral trial box and rotate posteriorly until seated (Figures 54 and 55). Figure 54 Figure 55 Cam Modules Femoral Trial sz 5 71433365 Left sz 5 71433345 Right sz 5 71433355 26  Tibial component trialing 1 Use the appropriate insert trial (begin with a 9mm trial) to determine stability and alignment. 2 Perform a trial range of motion. The alignment marks on the front of the femoral and tibial trials should line up (Figure 56). The quick- connect handle may be attached to the tibial trial and used to set the appropriate rotational alignment. Optional Extend the knee fully with the Figure 56 handle attached to the tibial trial. Pass the extramedullary rod through the handle to assess full leg alignment (Figure 57). Figure 57 PS High Flex Insert PS Insert Trials Constrained Insert Insert Trial Spacers Trials 9mm Trials 13mm 9mm sz 3-4 71430815 9mm sz 3-4 74033634 sz 3-4 71430408 11mm sz 3-4 71440473 15mm 10mm sz 3-4 71430817 11mm sz 3-4 74033635 sz 3-4 71433453 sz 3-4 71430524 18mm 11mm CR Insert Trials Deep Dished sz 3-4 74033636 sz 3-4 71430409 9mm Insert Trials 21mm 12mm sz 3-4 71430490 9mm sz 3-4 74033637 sz 3-4 71433454 11mm sz 3-4 71430766 sz 3-4 71430492 11mm sz 3-4 71430768 CR Deep Flex Insert Trials 9mm sz 3-4 71430444 10mm sz 3-4 71433443 11mm sz 3-4 71430445 12mm Note: 10 and 12mm sz 3-4 71433444 Insert Trials are an Add-On Set 27 3 Mark correct tibial rotational alignment on the anterior tibia using a cautery knife (Figure 58). 4 If not previously performed, select the appropriate tibial fin punch to prepare the fins and punch through the tibial trial (Figure 59). Tip If the tibial bone is sclerotic, begin the fin slot with a burr or thin sawblade before using the fin punch to prevent tibial fracture. Figure 58 6 Remove the femoral and tibial trials. Figure 59 28  Component implantation Femoral implantation Cemented 1 Mix and prepare bone cement for femoral component and distal femur. Apply to the femoral component or prepared bone, based on the surgeon’s preference. Tip Many surgeons put cement on the bone rather than, or supplemental to, cement on the underside of the implant. Note: If using femoral lugs or Flex-Lok pegs with cemented posterior-stabilizing femorals, screw those components into the femoral prior to cement application. 2 Place the femoral implant onto the femur and use the femoral impactor to fully seat the implant Figure 60 (Figure 60). 3 Remove excess cement. Extend the knee to remove cement anteriorly without retracting the proximal soft tissue. Tip After tibial implant is implanted, place the tibial insert trial onto the tibial implant and extend the leg to pressurize the cement. Tip Place the CR tibial trial in the tibial implant tray to assist with aligning the femoral component during implantation. Porous 1 Ensure that flat, clean cuts are made to all of the femoral resection cuts. This will help to achieve an optimal press-fit. Tip Lavaging during resection helps ensure flat, clean cuts. 2 Place the femoral implant onto the femur and use the femoral impactor to fully seat the implant. Tip If extraction of the femoral component is needed, attach the locking impactor and move in side-to-side motions to leverage off, then adjust and reimpact. OXINIUM™ CR Femoral Impactor PS Femoral Impactor Impactor (Universal 71440190 71440005 Impactor) 71440890 29  Tibial implantation Apply cement on the proximal tibia and/or the implant, tibial insert covers on the articular surface of the baseplate, and seat the tibial implant with the tibial impactor (Figure 61). Remove excess cement. Recommended Insert Placement Method 1 Clear any debris from the locking mechanism and manually slide the insert into the tibial baseplate engaging the locking mechanism until the insert periphery is within 1-2mm of the Tibial Figure 61 Component periphery. 2 Insert the tip of the JOURNEY™ Articular Insert Tool into the center notch of the anterior lock detail (handle up) and engage the two tabs of the Tool into the two recesses on the anterior periphery of the insert (Figure 62). Note: Make sure the tool is level with the plane of the baseplate. 3 Squeeze the tool handle until the insert is fully seated within the Tibial Component. The insert Figure 62 should not move under any pressure in flexion or extension. Cruciate-retaining, dished and posterior stabilized insert placement 1 Determine the correct articular insert thickness. 2 Clear any debris from the locking mechanism and manually slide the insert into the tibial baseplate engaging the locking mechanism. For the PS insert, begin insertion in flexion and extend the leg to engage the locking mechanism. 3 Attach the articular inserter/extractor to the tibial tray. Lift the inserter superiorly until the anterior lip of the articular insert is fully seated (Figure 63). Figure 63 Tibial Base Articular Inserter/ JOURNEY Articular Impactor Extractor Inserter Tool 74018901 71440194 74018911 30  PS and CR high flex insert placement 1 Attach the appropriately sized impactor head (either 1-2 or 3-8) to the impactor handle. 2 Position the knee in approximately 90° flexion. 3 Align the articular insert with the locking Figure 64 mechanism of the tibial baseplate. 4 Push the insert posteriorly until the top of the anterior rail of the baseplate is visible. 5 Place the impactor head on the anterior chamfer of the insert. The mating surfaces should be very conforming (Figures 64 and 65). 6 Impact the handle until the insert is fully seated. Figure 65 High-flex Impactor High-flex Impactor Head Handle sz 1-2 71441553 71441552 sz 3-8 71441554 31  MIS PS high flex insert placement When using the PS high flex insert in a minimally invasive procedure, the femoral cam mechanism is likely to prevent the insert from fully seating into the locking mechanism while the knee is in flexion. To use the PS high flex insert in a MIS case: 1 Flex the knee to 90° and push the insert as far Figure 66 back as it will go posteriorly with the knee in flexion (Figure 66). Tip Lift the distal femur to prevent scratching of the posterior condyle of the component. 2 Placing your thumb on the anterior of the insert to hold it on the baseplate (Figure 67), move the knee into extension. 3 Use the impactor handle with the appropriately Figure 67 sized impactor head to fully seat the insert and engage the anterior portion of the dovetail locking mechanism (Figure 68). Figure 68 32  Options/Alternatives Patella preparation Locking Screw Instrument assembly Patellar Reamer Guide Determine the appropriate diameter patellar implant, and select the correctly-sized Patellar Reamer Collet and slide it into place on the Reamer Collet Patellar Reamer Guide (Figure 69). Depth gauge and reamer assembly 1 Attach the appropriate patellar depth gauge Figure 80 Figure 69 Reamer Guide (red = resurfacing, black = large resurfacing/ round) to the Reamer Guide (Figure 70). 2 Attach the matching sized patellar reamer dome and patellar depth stop to the patellar reamer shaft (Figures 71 and 72). Lower the assembly through the patellar Reamer Guide until the reamer dome contacts the patella. Figure 70 Reamer Dome Figure 71 Figure 72 Reamer Collet Resurfacing Depth Patellar Depth Reamer Shaft 26mm 71440512 Gauge Stop 71440324 29mm 71440514 71440330 71440326 Reamer Dome 32mm 71440516 26mm 71440348 35mm 71440518 Large Resurfacing/ Large Resurfacing/ 29mm 71440342 Oval Depth Gauge Oval Depth Stop 32mm 71440344 Reamer Guide 71440431 71440427 35mm 71440346 71440311 33  Resurfacing patellar preparation The surgeon can choose from a freehand cutting technique with towel clips, or if desired, they can choose one of the following instrumented techniques. Reaming technique The objective of this technique is to resurface the articular surface of the patella with the precision of a reaming technique. The reamed patellar surface can accommodate an oval or round resurfacing patellar component. 1 Trim tissue surrounding the patella using electrocautery (bovie) (Figure 73). Figure 73 2 Use a rongeur to remove osteophytes and reduce the patella to its true size (Figure 74). It is recommended to leave the superior rim of bone intact. The bovie should also be used to release soft tissue attachments to the estimated level of resection. 3 Place the collet over the patella so that it fits snugly around the patellar diameter (Figure 75). The goal is to reduce the patella to its smallest Figure 74 diameter so that the smallest possible collet will fit around the entire patella. Use the patellar reamer collet as a sizing template to select the appropriately sized collet and reamer. Tip The collet should be resting on the soft tissue surrounding the patella. If the patella does not enter the collet evenly but instead enters at an angle, the collet may not be completely surrounding the patella, but instead resting on part of the bone. If the collet is only slightly smaller than the patella, you may trim 1-2mm of the medial and lateral edges of the patella to ensure a Figure 75 snug fit. If the collet is far smaller than the patella, choose the next size up and assess fit. Resurfacing Drill Drill Patellar Calipers Reamer Collet Guide 71440360 11-4943 26mm 71440512 26mm 71440402 29mm 71440514 29mm 71440403 32mm 71440516 32mm 71440404 35mm 71440518 35mm 71440405 34 4 Measure patella thickness with the patellar calipers (Figure 76). Tip The patella should measure a minimum of 19mm before reaming to use this resurfacing Collet technique. Determine the design and diameter of the patellar implant to be used. The round resurfacing patella is 9mm thick, and the Figure 76 depth stop for this technique prepares for 9mm of resection. Tip Minor adjustments may be necessary at the time of resection to accommodate the largest Depth Stop diameter oval patellar implants. (Please see chart on page 44). 5 Rotate the appropriate resurfacing patellar depth gauge (red = round) Depth Gauge around so that the hooked end or ‘claw’ surrounds the patellar reamer shaft (Figure 77). Lower the depth stop by compressing the button until it meets the depth gauge (Figure 78). Remove the depth gauge from the assembly. Clamp Ream the patella until the depth stop engages Figure 77 the patellar Reamer Guide (Figure 79). Tip Excessive force on the reamer shaft may alter the depth of resection, causing overreaming. Figure 78 Figure 79 Resurfacing Depth Reamer Dome Reamer Guide Stop 26mm 71440348 71440311 71440326 29mm 71440342 32mm 71440344 Resurfacing Depth Reamer Shaft 35mm 71440346 Gauge 71440324 71440330 35 6 After reaming, the patella should have a completely flat articular surface (Figure 80). Measure the resected patella to ensure adequate resection (the resected patella should measure its original depth minus 9mm). 7 Drill the appropriate fixation holes for the Target Depth resurfacing patellar implant using the correctly Original Depth - 9mm sized drill guide and resurfacing drill (Figure 81). 8 Place the patellar trial into the prepared patella. Collet If desired, use the calipers to remeasure the composite thickness of bone and trial (Figure 82). Figure 80 Drill Guide Drill Figure 81 Figure 82 Resurfacing Drill Drill Patellar Calipers Guide 71440360 114943 26mm 71440402 29mm 71440403 32mm 71440404 35mm 71440405 36  Component trialing 1 Place the patellar trial into the prepared patella (Figure 83). 2 Perform a trial range of motion to assess patellar tracking. Medial/lateral placement of the femoral trial can be adjusted to optimize patellar tracking (Figure 84). Figure 83 Figure 84 Patellar implantation 1 Assemble the patellar cement clamp to the Clamp patellar Reamer Guide. 2 Apply bone cement to the patella. 3 Place the patellar implant onto the patella and clamp into the bone (Figure 85). Remove excess cement. Figure 85 Resurfacing Reamer Guide Cement Clamp Patellar Trial 71440311 71440322 26mm 71430580 29mm 71430574 32mm 71430576 35mm 71430578 37 Intramedullary (IM) tibial preparation Technique highlights Place the IM alignment assembly on the tibia. The alignment rod should align with the medial third of the tibial tubercle. Impact assembly. Attach the tibial stylus to the tibial cutting block and lower the cutting block until the stylus touches the low point on the least affected side of the tibia. Once the resection level is determined, insert pins to secure and remove alignment assembly. Resect the proximal tibia. Size the tibia. Final preparation After trial range of motion and alignment checks, select the appropriate trial fin punch and punch through the trial. Seat the tibial implant with the tibial impactor. Insert the articular insert by placing the insert assembly tool into the center notch of the anterior lock detail (handle up) and engage the two tabs of the tool into the two recesses on the anterior periphery of the insert. Squeeze the tool handle until the insert is fully seated within the tibial component. 38  Instrument assembly Intramedullary Tibial Alignment Guide 1 Insert the external rod of the Intramedullary Tibial Alignment Guide through the hole on the correct left or right Tibial Cutting Block and lock Alignment Sleeve the cam (Figure 86). 2 Attach the T-handle to the IM Rod and pass it through the cannulated alignment sleeve on the alignment assembly (Figure 87). Alignment Rod Figure 86 Figure 87 T-handle Tibial Cutting Block IM Alignment IM Rod 71110080 Left 71441136 Guide Short 71512035 Right 71441137 71440200 Long 71512040 39  IM tibial preparation 1 Make a 9.5mm pilot hole into the tibial canal (Figure 88). A preliminary resection of the tibial spine may facilitate seating of the tibial drill guide onto the proximal tibia. 2 Slowly insert the IM rod into the tibial canal. 3 Assess rotation of the intramedullary tibial Figure 88 alignment guide. Rotational alignment is critical due to the 3º posterior sloped cut. The alignment rod of the intramedullary tibial alignment assembly should align with the medial third of the tibial tubercle (Figure 89). 4 Impact the proximal end of the cannulated alignment sleeve to drive the distal spikes into the proximal tibia to lock rotational alignment (Figure 90). Figure 89 Figure 90 Tibial Cutting Block IM Alignment IM Rod IM Drill Left 71441136 Guide Short 71512035 74012111 Right 71441137 71440200 Long 71512040 40  Tibial resection 1 Attach the Tibial Stylus to the Tibial Cutting Block by inserting the stylus foot into the cutting slot. 2 Lower the cutting block until the stylus touches the low point on the least affected side of the tibia (Figure 91). The stylus can be adjusted for a 1-13mm tibial resection by twisting the knob on top of the stylus. If the affected side of the tibia is to be used as a reference, the stylus may be adjusted for a 1-9mm resection level. Figure 91 3 Pin the Tibial Cutting Block to the tibia by inserting pins first through the central holes; then the oblique hole. Tip Pinning through the central holes marked 0mm with smooth pins will allow the block to be moved +2mm should additional resection be required (Figure 92). Tip A 9mm resection is recommended since 9mm of metal and plastic is the thinnest available component. Figure 92 Tip To do an extramedullary alignment check, place the extramedullary Alignment Rod through the tibial cutting block. Tibial Stylus Tibial Cutting Block Alignment Rod 71441143 Left 71441136 71441148 Right 71441137 41 4 To remove the assembly: Use the universal extractor leaving the cutting block on the anterior tibia (Figure 93) after loosening the thumbscrew. 5 Cut the tibia by first directing the blade in the posterior direction and then laterally (Figure 94). 6 Check alignment and balance with spacer block and rod. Balance ligaments in standard fashion. Figure 93 Figure 94 Universal Extractor Flexion / Extension Quick Connect Alignment Rod (Slap Hammer) Spacers Handle 71441148 71440366 9mm 74018608 71440044 11mm 74018611 Flexion / Extension 13mm 74018613 Tibial Cutting Block Block Standard 15mm 74018615 Left 71441136 74018603 18mm 74018618 Right 71441137 21mm 74018621 42 Appendix A Implant size interchangeability Femoral Size Insert Size 1 2 3 4 5 6 7 8 1-2 PS, DD, Con 1-2 PSHF, CRHF 3-4 PS, DD, Con 3-4 PSHF, CRHF 5-6 PS, DD, Con 5-6 PSHF, CRHF 7-8 PS, DD, Con 7-8 PSHF, CRHF PS – Standard posterior stabilized DD – Deep dish Con – Constrained PSHF – Posterior stabilized high flex CRHF – Cruciate retaining high flex Note: CR – Standard cruciate retaining inserts are interchangeable with all size femoral components 43 Catalog Information LEGION™ PS OXINIUM™ Femorals LEGION Narrow CR OXINIUM Femorals Cat. No. Description Cat. No. Description 71421202 LEGION PS OXINIUM Femoral Size 2 Right 71421243 LEGION Narrow CR OXINIUM Size 3N Left 71421203 LEGION PS OXINIUM Femoral Size 3 Right 71421244 LEGION Narrow CR OXINIUM Size 4N Left 71421204 LEGION PS OXINIUM Femoral Size 4 Right 71421245 LEGION Narrow CR OXINIUM Size 5N Left 71421205 LEGION PS OXINIUM Femoral Size 5 Right 71421246 LEGION Narrow CR OXINIUM Size 6N Left 71421206 LEGION PS OXINIUM Femoral Size 6 Right 71421253 LEGION Narrow CR OXINIUM Size 3N Right 71421207 LEGION PS OXINIUM Femoral Size 7 Right 71421254 LEGION Narrow CR OXINIUM Size 4N Right 71421208 LEGION PS OXINIUM Femoral Size 8 Right 71421255 LEGION Narrow CR OXINIUM Size 5N Right 71421212 LEGION PS OXINIUM Femoral Size 2 Left 71421256 LEGION Narrow CR OXINIUM Size 6N Right 71421213 LEGION PS OXINIUM Femoral Size 3 Left 71421214 LEGION PS OXINIUM Femoral Size 4 Left LEGION CR Non-Porous Femorals 71421215 LEGION PS OXINIUM Femoral Size 5 Left Cat. No. Description 71421216 LEGION PS OXINIUM Femoral Size 6 Left 71423202 LEGION CR Non-Porous Femoral Size 2 Left 71421217 LEGION PS OXINIUM Femoral Size 7 Left 71423203 LEGION CR Non-Porous Femoral Size 3 Left 71421218 LEGION PS OXINIUM Femoral Size 8 Left 71423204 LEGION CR Non-Porous Femoral Size 4 Left 71423205 LEGION CR Non-Porous Femoral Size 5 Left LEGION CR OXINIUM Femorals 71423206 LEGION CR Non-Porous Femoral Size 6 Left Cat. No. Description 71423207 LEGION CR Non-Porous Femoral Size 7 Left 71421222 LEGION CR OXINIUM Femoral Size 2 Right 71423208 LEGION CR Non-Porous Femoral Size 8 Left 71421223 LEGION CR OXINIUM Femoral Size 3 Right 71423212 LEGION CR Non-Porous Femoral Size 2 Right 71421224 LEGION CR OXINIUM Femoral Size 4 Right 71423213 LEGION CR Non-Porous Femoral Size 3 Right 71421225 LEGION CR OXINIUM Femoral Size 5 Right 71423214 LEGION CR Non-Porous Femoral Size 4 Right 71421226 LEGION CR OXINIUM Femoral Size 6 Right 71423215 LEGION CR Non-Porous Femoral Size 5 Right 71421227 LEGION CR OXINIUM Femoral Size 7 Right 71423216 LEGION CR Non-Porous Femoral Size 6 Right 71421228 LEGION CR OXINIUM Femoral Size 8 Right 71423217 LEGION CR Non-Porous Femoral Size 7 Right 71421232 LEGION CR OXINIUM Femoral Size 2 Left 71423218 LEGION CR Non-Porous Femoral Size 8 Right 71421233 LEGION CR OXINIUM Femoral Size 3 Left 71421234 LEGION CR OXINIUM Femoral Size 4 Left 71421235 LEGION CR OXINIUM Femoral Size 5 Left LEGION PS Non-Porous Femorals 71421236 LEGION CR OXINIUM Femoral Size 6 Left Cat. No. Description 71421237 LEGION CR OXINIUM Femoral Size 7 Left 71423222 LEGION PS Non-Porous Femoral Size 2 Left 71421238 LEGION CR OXINIUM Femoral Size 8 Left 71423223 LEGION PS Non-Porous Femoral Size 3 Left 71423224 LEGION PS Non-Porous Femoral Size 4 Left 71423225 LEGION PS Non-Porous Femoral Size 5 Left LEGION Narrow PS OXINIUM Femorals 71423226 LEGION PS Non-Porous Femoral Size 6 Left Cat. No. Description 71423227 LEGION PS Non-Porous Femoral Size 7 Left 71421263 LEGION Narrow PS OXINIUM Size 3N Left 71423228 LEGION PS Non-Porous Femoral Size 8 Left 71421264 LEGION Narrow PS OXINIUM Size 4N Left 71423232 LEGION PS Non-Porous Femoral Size 2 Right 71421265 LEGION Narrow PS OXINIUM Size 5N Left 71423233 LEGION PS Non-Porous Femoral Size 3 Right 71421266 LEGION Narrow PS OXINIUM Size 6N Left 71423234 LEGION PS Non-Porous Femoral Size 4 Right 71421273 LEGION Narrow PS OXINIUM Size 3N Right 71423235 LEGION PS Non-Porous Femoral Size 5 Right 71421274 LEGION Narrow PS OXINIUM Size 4N Right 71423236 LEGION PS Non-Porous Femoral Size 6 Right 71421275 LEGION Narrow PS OXINIUM Size 5N Right 71423237 LEGION PS Non-Porous Femoral Size 7 Right 71421276 LEGION Narrow PS OXINIUM Size 6N Right 71423238 LEGION PS Non-Porous Femoral Size 8 Right 44 LEGION™ Porous CR Femorals LEGION CR Non-Porous Narrow Femorals Cat. No. Description Cat. No. Description 71423242 LEGION Porous CR Femoral Size 2 Left 71933640 LEGION CR Non-Porous Narrow Femoral Size 3 Left 71423243 LEGION Porous CR Femoral Size 3 Left 71933641 LEGION CR Non-Porous Narrow Femoral Size 4 Left 71423244 LEGION Porous CR Femoral Size 4 Left 71933642 LEGION CR Non-Porous Narrow Femoral Size 5 Left 71423245 LEGION Porous CR Femoral Size 5 Left 71933643 LEGION CR Non-Porous Narrow Femoral Size 6 Left 71423246 LEGION Porous CR Femoral Size 6 Left 71933644 LEGION CR Non-Porous Narrow Femoral Size 3 Right 71423247 LEGION Porous CR Femoral Size 7 Left 71933645 LEGION CR Non-Porous Narrow Femoral Size 4 Right 71423248 LEGION Porous CR Femoral Size 8 Left 71933646 LEGION CR Non-Porous Narrow Femoral Size 5 Right 71423252 LEGION Porous CR Femoral Size 2 Right 71933647 LEGION CR Non-Porous Narrow Femoral Size 6 Right 71423253 LEGION Porous CR Femoral Size 3 Right 71423254 LEGION Porous CR Femoral Size 4 Right 71423255 LEGION Porous CR Femoral Size 5 Right 71423256 LEGION Porous CR Femoral Size 6 Right LEGION PS Non-Porous Narrow Femorals Cat. No. Description 71423257 LEGION Porous CR Femoral Size 7 Right 71933648 LEGION PS Non-Porous Narrow Femoral Size 3 Left 71423258 LEGION Porous CR Femoral Size 8 Right 71933649 LEGION PS Non-Porous Narrow Femoral Size 4 Left 71933650 LEGION PS Non-Porous Narrow Femoral Size 5 Left 71933651 LEGION PS Non-Porous Narrow Femoral Size 6 Left LEGION Porous CR HA Femorals 71933652 LEGION PS Non-Porous Narrow Femoral Size 3 Right Cat. No. Description 71933653 LEGION PS Non-Porous Narrow Femoral Size 4 Right 71425202 LEGION Porous CR HA Femoral Size 2 Left 71933654 LEGION PS Non-Porous Narrow Femoral Size 5 Right 71425203 LEGION Porous CR HA Femoral Size 3 Left 71933655 LEGION PS Non-Porous Narrow Femoral Size 6 Right 71425204 LEGION Porous CR HA Femoral Size 4 Left 71425205 LEGION Porous CR HA Femoral Size 5 Left 71425206 LEGION Porous CR HA Femoral Size 6 Left 71425207 LEGION Porous CR HA Femoral Size 7 Left 71425208 LEGION Porous CR HA Femoral Size 8 Left 71425212 LEGION Porous CR HA Femoral Size 2 Right 71425213 LEGION Porous CR HA Femoral Size 3 Right 71425214 LEGION Porous CR HA Femoral Size 4 Right 71425215 LEGION Porous CR HA Femoral Size 5 Right 71425216 LEGION Porous CR HA Femoral Size 6 Right 71425217 LEGION Porous CR HA Femoral Size 7 Right 71425218 LEGION Porous CR HA Femoral Size 8 Right 45 LEGION™ CR High Flex XLPE Inserts LEGION PS High Flex XLPE Inserts Cat. No. Description Cat. No. Description 71453101 LEGION CR High Flex XLPE Inserts Size 1-2 9mm 71453171 LEGION PS High Flex XLPE Inserts Size 1-2 10mm 71453102 LEGION CR High Flex XLPE Inserts Size 1-2 11mm 71453172 LEGION PS High Flex XLPE Inserts Size 1-2 12mm 71453103 LEGION CR High Flex XLPE Inserts Size 1-2 13mm 71453173 LEGION PS High Flex XLPE Inserts Size 3-4 10mm 71453104 LEGION CR High Flex XLPE Inserts Size 1-2 15mm 71453174 LEGION PS High Flex XLPE Inserts Size 3-4 12mm 71453105 LEGION CR High Flex XLPE Inserts Size 1-2 18mm 71453175 LEGION PS High Flex XLPE Inserts Size 5-6 10mm 71453111 LEGION CR High Flex XLPE Inserts Size 3-4 9mm 71453176 LEGION PS High Flex XLPE Inserts Size 5-6 12mm 71453112 LEGION CR High Flex XLPE Inserts Size 3-4 11mm 71453177 LEGION PS High Flex XLPE Inserts Size 7-8 10mm 71453113 LEGION CR High Flex XLPE Inserts Size 3-4 13mm 71453178 LEGION PS High Flex XLPE Inserts Size 7-8 12mm 71453114 LEGION CR High Flex XLPE Inserts Size 3-4 15mm 71453201 LEGION PS High Flex XLPE Inserts Size 1-2 9mm 71453115 LEGION CR High Flex XLPE Inserts Size 3-4 18mm 71453202 LEGION PS High Flex XLPE Inserts Size 1-2 11mm 71453121 LEGION CR High Flex XLPE Inserts Size 5-6 9mm 71453203 LEGION PS High Flex XLPE Inserts Size 1-2 13mm 71453122 LEGION CR High Flex XLPE Inserts Size 5-6 11mm 71453204 LEGION PS High Flex XLPE Inserts Size 1-2 15mm 71453123 LEGION CR High Flex XLPE Inserts Size 5-6 13mm 71453205 LEGION PS High Flex XLPE Inserts Size 1-2 18mm 71453124 LEGION CR High Flex XLPE Inserts Size 5-6 15mm 71453206 LEGION PS High Flex XLPE Inserts Size 1-2 21mm 71453125 LEGION CR High Flex XLPE Inserts Size 5-6 18mm 71453211 LEGION PS High Flex XLPE Inserts Size 3-4 9mm 71453131 LEGION CR High Flex XLPE Inserts Size 7-8 9mm 71453212 LEGION PS High Flex XLPE Inserts Size 3-4 11mm 71453132 LEGION CR High Flex XLPE Inserts Size 7-8 11mm 71453213 LEGION PS High Flex XLPE Inserts Size 3-4 13mm 71453133 LEGION CR High Flex XLPE Inserts Size 7-8 13mm 71453214 LEGION PS High Flex XLPE Inserts Size 3-4 15mm 71453134 LEGION CR High Flex XLPE Inserts Size 7-8 15mm 71453215 LEGION PS High Flex XLPE Inserts Size 3-4 18mm 71453135 LEGION CR High Flex XLPE Inserts Size 7-8 18mm 71453216 LEGION PS High Flex XLPE Inserts Size 3-4 21mm 71453181 LEGION CR High Flex XLPE Inserts Size 1-2 10mm 71453221 LEGION PS High Flex XLPE Inserts Size 5-6 9mm 71453182 LEGION CR High Flex XLPE Inserts Size 1-2 12mm 71453222 LEGION PS High Flex XLPE Inserts Size 5-6 11mm 71453183 LEGION CR High Flex XLPE Inserts Size 3-4 10mm 71453223 LEGION PS High Flex XLPE Inserts Size 5-6 13mm 71453184 LEGION CR High Flex XLPE Inserts Size 3-4 12mm 71453224 LEGION PS High Flex XLPE Inserts Size 5-6 15mm 71453185 LEGION CR High Flex XLPE Inserts Size 5-6 10mm 71453225 LEGION PS High Flex XLPE Inserts Size 5-6 18mm 71453186 LEGION CR High Flex XLPE Inserts Size 5-6 12mm 71453226 LEGION PS High Flex XLPE Inserts Size 5-6 21mm 71453187 LEGION CR High Flex XLPE Inserts Size 7-8 10mm 71453231 LEGION PS High Flex XLPE Inserts Size 7-8 9mm 71453188 LEGION CR High Flex XLPE Inserts Size 7-8 12mm 71453232 LEGION PS High Flex XLPE Inserts Size 7-8 11mm 71453233 LEGION PS High Flex XLPE Inserts Size 7-8 13mm 71453234 LEGION PS High Flex XLPE Inserts Size 7-8 15mm 71453235 LEGION PS High Flex XLPE Inserts Size 7-8 18mm 71453236 LEGION PS High Flex XLPE Inserts Size 7-8 21mm 46 LEGION™ XLPE Dished Inserts GENESIS™ II Tibial Baseplates (Cemented) Cat. No. Description Cat. No. Description 71453271 LEGION XLPE Dished Insert Size 1-2 9mm 71420160 GENESIS II Cemented Tibial Baseplate Size 1 Left 71453272 LEGION XLPE Dished Insert Size 1-2 11mm 71420162 GENESIS II Cemented Tibial Baseplate Size 2 Left 71453273 LEGION XLPE Dished Insert Size 1-2 13mm 71420164 GENESIS II Cemented Tibial Baseplate Size 3 Left 71453274 LEGION XLPE Dished Insert Size 1-2 15mm 71420166 GENESIS II Cemented Tibial Baseplate Size 4 Left 71453275 LEGION XLPE Dished Insert Size 1-2 18mm 71420168 GENESIS II Cemented Tibial Baseplate Size 5 Left 71253276 LEGION XLPE Dished Insert Size 1-2 21mm 71420170 GENESIS II Cemented Tibial Baseplate Size 6 Left 71453277 LEGION XLPE Dished Insert Size 3-4 9mm 71420172 GENESIS II Cemented Tibial Baseplate Size 7 Left 71453278 LEGION XLPE Dished Insert Size 3-4 11mm 71420174 GENESIS II Cemented Tibial Baseplate Size 8 Left 71453279 LEGION XLPE Dished Insert Size 3-4 13mm 71420176 GENESIS II Cemented Tibial Baseplate Size 1 Right 71453281 LEGION XLPE Dished Insert Size 3-4 15mm 71420180 GENESIS II Cemented Tibial Baseplate Size 2 Right 71453282 LEGION XLPE Dished Insert Size 3-4 18mm 71420182 GENESIS II Cemented Tibial Baseplate Size 3 Right 71453283 LEGION XLPE Dished Insert Size 3-4 21mm 71420184 GENESIS II Cemented Tibial Baseplate Size 4 Right 71453284 LEGION XLPE Dished Insert Size 5-6 9mm 71420186 GENESIS II Cemented Tibial Baseplate Size 5 Right 71453285 LEGION XLPE Dished Insert Size 5-6 11mm 71420188 GENESIS II Cemented Tibial Baseplate Size 6 Right 71453286 LEGION XLPE Dished Insert Size 5-6 13mm 71420191 GENESIS II Cemented Tibial Baseplate Size 8 Right 71453287 LEGION XLPE Dished Insert Size 5-6 15mm 71931716 GENESIS II Cemented Tibial Baseplate Size 9 Right 71453288 LEGION XLPE Dished Insert Size 5-6 18mm 71931923 GENESIS II Cemented Tibial Baseplate Size 9 Left 71453289 LEGION XLPE Dished Insert Size 5-6 21mm 71453291 LEGION XLPE Dished Insert Size 7-8 9mm 71453292 LEGION XLPE Dished Insert Size 7-8 11mm 71453293 LEGION XLPE Dished Insert Size 7-8 13mm 71453294 LEGION XLPE Dished Insert Size 7-8 15mm 71453295 LEGION XLPE Dished Insert Size 7-8 18mm 71453296 LEGION XLPE Dished Insert Size 7-8 21mm 47 LEGION™ Porous HA Tibial Baseplate with Holes GENESIS™ II Round Resurfacing Patellae Cat. No. Description Cat. No. Description 71934054 LEGION Porous HA Tibial Baseplate Size 2 Left 71420574 GENESIS II Round Resurfacing Patella 29mm 71934055 LEGION Porous HA Tibial Baseplate Size 3 Left 71420576 GENESIS II Round Resurfacing Patella 32mm 71934056 LEGION Porous HA Tibial Baseplate Size 4 Left 71420578 GENESIS II Round Resurfacing Patella 35mm 71934057 LEGION Porous HA Tibial Baseplate Size 5 Left 71420580 GENESIS II Round Resurfacing Patella 26mm 71934058 LEGION Porous HA Tibial Baseplate Size 6 Left 71926225 GENESIS II Round Resurfacing Patella 38mm 71934059 LEGION Porous HA Tibial Baseplate Size 7 Left 71926226 GENESIS II Round Resurfacing Patella 41mm 71934060 LEGION Porous HA Tibial Baseplate Size 8 Left 71934061 LEGION Porous HA Tibial Baseplate Size 2 Right 71934062 LEGION Porous HA Tibial Baseplate Size 3 Right 71934063 LEGION Porous HA Tibial Baseplate Size 4 Right GENESIS II Oval Resurfacing Patellae 71934064 LEGION Porous HA Tibial Baseplate Size 5 Right Cat. No. Description 71934065 LEGION Porous HA Tibial Baseplate Size 6 Right 71421029 GENESIS II Oval Resurfacing Patella 29mm 71934066 LEGION Porous HA Tibial Baseplate Size 7 Right 71421032 GENESIS II Oval Resurfacing Patella 32mm 71934067 LEGION Porous HA Tibial Baseplate Size 8 Right 71421035 GENESIS II Oval Resurfacing Patella 35mm 71421038 GENESIS II Oval Resurfacing Patella 38mm 71421041 GENESIS II Oval Resurfacing Patella 41mm LEGION Porous HA Tibial Baseplate without Holes Cat. No. Description 71934161 LEGION Porous HA Tibial Baseplate without Holes Size 2 Left 71934162 LEGION Porous HA Tibial Baseplate without Holes Size 3 Left GENESIS II Biconvex Resurfacing Patellae 71934163 LEGION Porous HA Tibial Baseplate without Holes Size 4 Left Cat. No. Description 71934164 LEGION Porous HA Tibial Baseplate without Holes Size 5 Left 71420566 GENESIS II Biconvex Resurfacing Patella 23mm 71934165 LEGION Porous HA Tibial Baseplate without Holes Size 6 Left 71420568 GENESIS II Biconvex Resurfacing Patella 26mm 71934166 LEGION Porous HA Tibial Baseplate without Holes Size 7 Left 71420570 GENESIS II Biconvex Resurfacing Patella 29mm 71934167 LEGION Porous HA Tibial Baseplate without Holes Size 8 Left 71420572 GENESIS II Biconvex Resurfacing Patella 32mm 71934168 LEGION Porous HA Tibial Baseplate without Holes Size 2 Right 71934169 LEGION Porous HA Tibial Baseplate without Holes Size 3 Right 71934170 LEGION Porous HA Tibial Baseplate without Holes Size 4 Right 71934171 LEGION Porous HA Tibial Baseplate without Holes Size 5 Right 71934172 LEGION Porous HA Tibial Baseplate without Holes Size 6 Right 71934173 LEGION Porous HA Tibial Baseplate without Holes Size 7 Right 71934174 LEGION Porous HA Tibial Baseplate without Holes Size 8 Right 48 PROFIX Metaphyseal Tibial Stems GENESIS II Femoral Flex-Lok Pegs Cat. No. Description Cat. No. Description 71501009 PROFIX Metaphyseal Tibial Stem 16mm 71420063 GENESIS II Femoral Flex-Lok Peg 71501010 PROFIX Metaphyseal Tibial Stem 18mm 71501020 PROFIX Metaphyseal Tibial Stem 20mm GENESIS II Primary Femoral Lug Cat. No. Description GENESIS™ II Tibial Bone Screws 71420999 GENESIS II Primary Femoral Lug Cat. No. Description 71420974 GENESIS II 6.5 mm Screw 15 mm Length 71420976 GENESIS II 6.5 mm Screw 20 mm Length 71420978 GENESIS II 6.5 mm Screw 25 mm Length 71420980 GENESIS II 6.5 mm Screw 30 mm Length 71420982 GENESIS II 6.5 mm Screw 35 mm Length GENESIS™ II Long Stems 71420984 GENESIS II 6.5 mm Screw 40 mm Length Cat. No. Description 71420986 GENESIS II 6.5 mm Screw 45 mm Length 71420628 GENESIS II Long Stem 10mm x 100mm 71420988 GENESIS II 6.5 mm Screw 50 mm Length 71420630 GENESIS II Long Stem 12mm x 100mm 71420632 GENESIS II Long Stem 14mm x 100mm 71420634 GENESIS II Long Stem 16mm x 100mm 71420636 GENESIS II Long Stem 18mm x 100mm 71420638 GENESIS II Long Stem 20mm x 100mm 71420640 GENESIS II Long Stem 22mm x 100mm 71420642 GENESIS II Long Stem 24mm x 100mm 71420647 GENESIS II Long Stem 10mm x 150mm with Slot 71420648 GENESIS II Long Stem 14mm x 150mm 71420649 GENESIS II Long Stem 12mm x 150mm with Slot 71420650 GENESIS II Long Stem 16mm x 150mm 49 LEGION™ CR TKS Implant Constructs Tibial Femoral Insert Patella Baseplate LEGION CR LEGION LEGION GENESIS™ II Non-Porous Femoral (CoCr) XLPE Dished Insert Revision Tibial Baseplate Round Resurfacing Patella (Cemented) LEGION CR LEGION CR GENESIS II Narrow Non-Porous High Flex XLPE Insert LEGION Oval Resurfacing Patella Femoral (CoCr) Porous HA Tibial Baseplate with Holes GENESIS II LEGION CR Biconvex Resurfacing Patella Porous Femoral (CoCr) LEGION Porous HA Tibial Baseplate LEGION CR without Holes Porous + HA Femoral (CoCr) LEGION CR Femoral (OXINIUM™) LEGION CR Narrow Femoral (OXINIUM) 50 LEGION™ CR Compatibility LEGION CR Femoral (OXINIUM™) LEGION XLPE Deep Dish Insert LEGION CR Narrow Femoral (OXINIUM) LEGION CR High Flex XLPE Insert LEGION CR Non-Porous Femoral (CoCr) LEGION CR Porous Femoral (CoCr) LEGION CR Porous HA Femoral (CoCr) LEGION CR Narrow Non-Porous Femoral (CoCr) Patella Inserts Tibial Baseplate Tibial Baseplate Femoral GENESIS™ II LEGION GENESIS II CR LEGION LEGION CR Round Resurfacing Patella XLPE Dished Insert All-Poly Tibial Baseplate Revision Tibial Baseplate Non-Porous Femoral (Cemented) (CoCr) GENESIS II LEGION CR Oval Resurfacing Patella High Flex XLPE Insert LEGION LEGION CR Porous HA Tibial Narrow Non-Porous GENESIS II GENESIS II CR Baseplate Femoral (CoCr) Biconvex Resurfacing Patella Insert with Holes LEGION CR GENESIS II CR LEGION Porous Femoral (CoCr) Deep Dish Insert Porous HA Tibial Baseplate LEGION CR GENESIS II CR without Holes Porous + HA Femoral High Flex (Deep Flex) (CoCr) Insert GENESIS II Tibial Baseplate LEGION CR (Cemented) Femoral (OXINIUM™) LEGION CR Narrow Femoral (OXINIUM) GENESIS II CR Femoral (CoCr) GENESIS II CR Femoral (OXINIUM) 51 Optional Compatibility for LEGION™ CR Femoral Components and Baseplates LEGION CR LEGION LEGION LEGION LEGION CR Narrow Non- Revision Tibial Porous HA Tibial Porous HA Non-Porous Porous Femoral Baseplate Baseplate with Tibial Baseplate Femoral (CoCr) (CoCr) (Cemented) Holes without Holes LEGION RK GENESIS II LEGION GENESIS II PROFIX Distal Femoral Wedge Femoral Flex-Lok Peg Finned Tibial Wedge Tibial Bone Screw Metaphyseal Tibial Stem (71501009, 71501010, LEGION RK LEGION RK/HK PROFIX 71501020) Posterior Femoral Wedge Hemi-Stepped Tibial Wedge Metaphyseal Tibial Stem (71501009, 71501010, GENESIS II LEGION RK LEGION RK/HK 71501020) Long Stem “L” Femoral Wedge Full-Stepped Tibial Wedge GENESIS II LEGION LEGION Long Stem Distal Wedge Screw Tibial Wedge Screw LEGION LEGION Posterior Wedge Screw Locking Set Screw GENESIS™ II LEGION Femoral Flex-Lok Peg Tibial Wedge Lug LEGION Tibial Cone LEGION Press-fit Stem LEGION Cemented Stem LEGION Stem Extension LEGION Offset Coupler LEGION Offset Coupler Angled LEGION Male to Male Mini Coupler 52 LEGION™ CR Component Size Compatibility LEGION Compatible Component Size Component LEGION CR Non-Porous LEGION XLPE Dish Insert Size 1-8, 9-21 mm Femoral (CoCr) LEGION CR High Flex XLPE Insert Size 1-8, 9-18 mm LEGION CR Narrow Non- Porous Femoral (CoCr) GENESIS™ II CR Insert Size 1-8, 9-18 mm LEGION CR Porous GENESIS II CR Deep Dish Insert Size 1-8, 9-21 mm Femoral (CoCr) GENESIS II CR High Flex (Deep Flex) Insert Size 1-8, 9-18 mm LEGION CR Porous + HA Femoral (CoCr) GENESIS II Round Resurfacing Patella 26-41 mm LEGION CR Femoral GENESIS II Oval Resurfacing Patella 29-41 mm (OXINIUM™) GENESIS II Biconvex Resurfacing Patella 23-32 mm LEGION CR Narrow Femoral (OXINIUM) GENESIS II CR All-Poly Tibial Baseplate Size 1-8, 9-15 mm, LT/RT LEGION Revision Knee Distal Femoral Wedge Size 2-8, 5-15 mm LEGION Revision Knee Posterior Femoral Wedge Size 1-8 LEGION Revision Knee “L” Femoral Wedge Size 2-8, 5-15 mm Distal LEGION CR Non-Porous x 5-10 mm Posterior Femoral (CoCr) LEGION Distal Wedge Screw 5-15 mm LEGION Posterior Wedge Screw 5-10 mm GENESIS II Femoral Flex-Lok Peg N/A LEGION CR Narrow Non- GENESIS II Femoral Flex-Lok Peg N/A Porous Femoral (CoCr) LEGION CR Non-Porous Femoral (CoCr) Size 2-8 LT/RT LEGION CR Narrow Non-Porous Femoral (CoCr) Size 3-6 LT/RT LEGION CR Porous Femoral (CoCr) Size 2-8 LT/RT LEGION CR Porous + HA Femoral (CoCr) Size 2-8 LT/RT LEGION LEGION CR Femoral (OXINIUM) Size 2-8 LT/RT XLPE Dished Insert LEGION CR Narrow Femoral (OXINIUM) Size 3-6 LT/RT LEGION CR High Flex XLPE Insert GENESIS II CR Femoral (CoCr) Size 1-8 LT/RT GENESIS II CR Femoral (OXINIUM) Size 2-9 LT/RT LEGION Revision Tibial Baseplate (Cemented) Size 1-8, LT/RT LEGION Porous HA Tibial Baseplate with Holes Size 2-8, LT/RT LEGION Porous HA Tibial Baseplate without Holes Size 2-8, LT/RT GENESIS II Tibial Baseplate (Cemented) Size 1-9, LT/RT 53 Compatibility Table (continued) LEGION™ Compatible Component Size Component LEGION Revision Tibial LEGION XLPE Dished Insert Size 1-8, 9-21 mm Baseplate (Cemented) LEGION CR High Flex Insert Size 1-8, 9-18 mm LEGION Porous HA Tibial GENESIS™ II CR Insert Size 1-8, 9-18 mm Baseplate with Holes LEGION Porous HA Tibial GENESIS II CR Deep Dish Insert Size 1-8, 9-21 mm Baseplate without Holes GENESIS II CR High Flex (Deep Flex) Insert Size 1-8, 9-18 mm LEGION Porous HA Tibial GENESIS II Tibial Bone Screw 15-50 mm Baseplate with Holes LEGION Porous HA Tibial PROFIX Metaphyseal Tibial Stem 16, 18, 20 mm Baseplate with Holes GENESIS II Long Stem 100, 150mm LEGION Porous HA Tibial Baseplate without Holes LEGION Finned Tibial Wedge Size 2-8, 10-20 mm LT/RT LEGION RK/HK Hemi-Stepped Tibial Wedge Size 1-8, 5-15 mm LL/RM LM/RL LEGION RK/HK Full-Stepped Tibial Wedge Size 1-8, 10-15 mm LEGION Tibial Wedge Screw N/A LEGION Locking Set Screw N/A LEGION Tibial Wedge Lug 10, 15 mm LEGION Tibial Cone 18-30 mm, Short/Long LEGION Revision Tibial LEGION Press-fit Stem 9-24 mm x 120 mm Baseplate (Cemented) 9-24 mm x 160 mm Straight - 10-24 mm x 220mm Bowed - 10-24 mm x 220mm Bowed - 10-24 mm x 280 mm LEGION Cemented Stem 10-20 mm x 120 mm 10-20 mm x 160 mm LEGION Stem Extension 10-14 mm x 80 mm LEGION Offset Coupler 2-6 mm LEGION Offset Coupler Angled N/A LEGION Male to Male Mini Coupler 2-6 mm 54 LEGION™ PS TKS Implant Constructs Tibial Femoral Insert Patella Baseplate LEGION PS LEGION PS LEGION GENESIS™ II Non-Porous Femoral (CoCr) High Flex XLPE Insert Revision Tibial Baseplate Round Resurfacing Patella (Cemented) LEGION PS LEGION GENESIS II Narrow Non-Porous Constrained Insert LEGION Oval Resurfacing Patella Femoral (CoCr) Porous HA Tibial Baseplate with Holes GENESIS II LEGION PS Biconvex Resurfacing Patella Femoral (OXINIUM™) LEGION Porous HA Tibial Baseplate LEGION PS without Holes Narrow Femoral (OXINIUM) LEGION RK Constrained Femoral (CoCr) LEGION RK Constrained Femoral (OXINIUM) 55 LEGION™ PS Compatibility LEGION PS Femoral LEGION LEGION PS LEGION PS LEGION (OXINIUM™) PS Femoral High Flex XLPE High Flex XLPE Constrained (OXINIUM) Insert Insert Insert* LEGION PS Narrow Femoral (OXINIUM) LEGION PS LEGION Narrow Femoral Constrained LEGION PS Non-Porous (OXINIUM) Femoral (CoCr) Insert* LEGION PS LEGION PS Narrow Non-Porous Non-Porous Femoral Femoral (CoCr) (CoCr) LEGION PS LEGION RK Constrained Narrow Femoral (CoCr) Non-Porous LEGION RK Constrained Femoral (CoCr) Femoral (OXINIUM) Patella Inserts Tibial Baseplate Tibial Baseplate Femoral Femoral GENESIS™ II LEGION PS GENESIS II LEGION RK LEGION PS LEGION PS Round Resurfacing High Flex XLPE PS All-Poly Tibial Baseplate Non-Porous Femoral (CoCr) Femoral (OXINIUM™) Patella Insert Tibial Baseplate Cemented) LEGION PS LEGION PS GENESIS II LEGION PS LEGION Narrow Non-Porous Narrow Femoral (OXINIUM) Oval Resurfacing Constrained Insert* Porous HA Tibial Baseplate Femoral (CoCr) Patella with Holes** LEGION PS GENESIS II PS LEGION PS Non-Porous Femoral (CoCr) GENESIS II Insert LEGION Femoral (OXINIUM™) Biconvex Porous HA Tibial Baseplate Resurfacing Patella GENESIS II PS without Holes** LEGION PS LEGION PS Narrow Non-Porous High Flex Insert Narrow Femoral (OXINIUM) GENESIS II Femoral (CoCr) GENESIS II Tibial Baseplate (Cemented) LEGION RK LEGION RK Constrained Insert* Constrained Femoral(CoCr) Constrained Femoral (CoCr) LEGION RK Constrained Femoral LEGION RK (OXINIUM) Constrained Femoral (OXINIUM) GENESIS II CR Non-Porous Femoral (CoCr)** GENESIS II CR Non-Porous Femoral (OXINIUM)** * Component must be used with the LEGION Femorals (CoCr and OXINIUM) and Tibial Stem ** Not compatible with LEGION and GENESIS II Constrained Insert 56 Optional Compatibility with LEGION™ PS LEGION PS LEGION RK LEGION PS Narrow Non-Porous Constrained Femoral Non-Porous Femoral Femoral (CoCr) (CoCr) (CoCr) LEGION PS LEGION RK LEGION PS Narrow Constrained Femoral Femoral (OXINIUM™) Femoral (OXINIUM) (OXINIUM) LEGION RK GENESIS II LEGION RK Distal Femoral Wedge Femoral Flex-Lok Peg Distal Femoral Wedge LEGION RK GENESIS II LEGION RK Posterior Femoral Wedge Primary Femoral Lug Posterior Femoral Wedge LEGION RK LEGION RK “L” Femoral Wedge “L” Femoral Wedge LEGION LEGION Distal Wedge Screw Distal Wedge Screw LEGION LEGION Posterior Wedge Screw Posterior Wedge Screw GENESIS™ II LEGION Femoral Flex-Lok Peg Locking Set Screw GENESIS II LEGION Primary Femoral Lug Femoral Cone LEGION Press-fit Stem LEGION Cemented Stem Straight LEGION Short Stem Extension LEGION Offset Coupler Angled LEGION Offset Coupler LEGION Male to Male Coupler 57 Optional Compatibility with LEGION™ PS (continued) LEGION™ RK LEGION LEGION Tibial Baseplate Porous HA Tibial Porous HA Tibial (Cemented) Baseplate with Holes Baseplate without Holes LEGION GENESIS II PROFIX Finned Tibial Wedge Tibial Bone Screw Metaphyseal Tibial Stem (71501009, 71501010, 71501020) LEGION RK/HK PROFIX Hemi-Stepped Tibial Wedge Metaphyseal Tibial Stem GENESIS II (71501009, 71501010, 71501020) Long Stem LEGION RK/HK Full-Stepped Tibial Wedge GENESIS II Long Stem LEGION Tibial Wedge Screw LEGION Locking Set Screw LEGION Tibial Wedge Lug LEGION Tibial Cone GENESIS™ II Long Stem LEGION Press-fit Stem LEGION Cemented Stem Straight LEGION Short Stem Extension LEGION Offset Coupler Angled LEGION Offset Coupler LEGION Male to Male Coupler 58 LEGION™ PS Component Size Compatibility LEGION Compatible Component Size Component LEGION PS Non-Porous LEGION PS High Flex XLPE Insert Size 1-8, 9-21 mm Femoral (CoCr) LEGION Constrained Insert* Size 1-8, 9 mm LEGION PS Narrow Non- Porous Femoral (CoCr) GENESIS™ II Constrained Insert* Size 1-8, 11-30 mm LEGION PS GENESIS II PS Insert Size 1-8, 9-25 mm Femoral (CoCr) GENESIS II PS High Flex Insert Size 1-8, 9-25 mm LEGION PS Narrow Femoral (OXINIUM™) GENESIS II Round Resurfacing Patella 26-41 mm LEGION RK Constrained GENESIS II Oval Resurfacing Patella 29-41 mm Femoral (CoCr) GENESIS II Biconvex Resurfacing Patella 23-32 mm LEGION RK Constrained Femoral (OXINIUM) LEGION PS GENESIS II PS All-Poly Tibial Baseplate Size 1-8, 9-15 mm LT/RT Femoral (OXINIUM) LEGION PS Narrow Femoral (OXINIUM™) LEGION PS Non-Porous GENESIS II Primary Femoral Lug N/A Femoral (CoCr) LEGION PS Narrow Non- Porous Femoral (CoCr) GENESIS II Femoral Flex-Lok Peg N/A LEGION PS Non-Porous LEGION Revision Knee Distal Femoral Wedge Size 2-8, 5-15 mm Femoral (CoCr) LEGION Revision Knee Posterior Femoral Wedge Size 1-8, 5-10 mm LEGION PS Femoral (OXINIUM) LEGION Revision Knee “L” Femoral Wedge Size 2-8, 5-15 mm Distal x 5-10 mm Posterior LEGION RK Constrained Femoral (CoCr) LEGION Distal Wedge Screw 5-15 mm LEGION RK Constrained LEGION Posterior Wedge Screw 5-10 mm Femoral (OXINIUM) LEGION Locking Set Screw N/A LEGION Femoral Cone 18-30 mm, LT/RT LEGION Press-fit Stem 9-24 mm x 120 mm 9-24 mm x 160 mm Straight - 10-24 mm x 220mm LEGION RK Constrained Bowed - 10-24 mm x 220mm Femoral (CoCr) Bowed - 10-24 mm x 280 mm LEGION RK Constrained LEGION Cemented Stem 10-20 mm x 160 mm Femoral (OXINIUM) LEGION Short Stem Extension 10-14 mm x 80 mm LEGION Offset Coupler Angled N/A LEGION Offset Coupler 2, 4, 6 mm LEGION Male to Male Mini Coupler 2, 4, 6 mm * Component must be used with the LEGION Femorals (CoCr and OXINIUM) and Tibial Stem 59 Compatibility Table (continued) LEGION™ Compatible Component Size Component LEGION PS Non-Porous Femoral (CoCr) Size 2-8 LT/RT LEGION PS Narrow Non-Porous Femoral (CoCr) Size 3-6 LT/RT LEGION PS Femoral (OXINIUM™) Size 2-8 LT/RT LEGION PS LEGION PS Narrow Femoral (OXINIUM) Size 3-6 LT/RT High Flex XLPE Insert LEGION RK Constrained Femoral (CoCr) Size 2-8 LT/RT LEGION Constrained Insert* LEGION RK Constrained Femoral (OXINIUM) Size 2-8 LT/RT GENESIS II Tibial Baseplate (Cemented) Size 1-9, LT/RT LEGION Revision Tibial Baseplate (Cemented) Size 1-8, LT/RT LEGION Porous HA Tibial Baseplate With Holes Size 2-8, LT/RT LEGION Porous HA Tibial Baseplate without Holes Size 2-8, LT/RT LEGION PS GENESIS II PS Femoral Component (CoCr)** Size 1-8 LT/RT High Flex XLPE Insert GENESIS II PS Femoral (OXINIUM)** Size 2-9 LT/RT * Component must be used with the LEGION Femorals (CoCr and OXINIUM) and Tibial Stem ** Not compatible with LEGION and GENESIS II Constrained Insert 60 Compatibility Table (continued) LEGION™ Compatible Component Size Component LEGION Revision Tibial LEGION PS High Flex XLPE Insert Size 1-8, 10-21 mm Baseplate (Cemented) LEGION Constrained Insert* Size 1-8, 9 mm LEGION Porous HA Tibial GENESIS™ II PS Insert Size 1-8, 9-25 mm Baseplate with Holes LEGION Porous HA Tibial GENESIS II PS High Flex Insert Size 1-8, 9-25 mm Baseplate without Holes GENESIS II Constrained Insert* Size 1-8, 11-30 mm LEGION Finned Tibial Wedge Size 2-8, 10-20 mm LT/RT LEGION RK/HK Hemi-Stepped Tibial Wedge Size 1-8, 5-15 mm LL/RM LM/RL LEGION RK/HK Full-Stepped Tibial Wedge Size 1-8, 10-15 mm LEGION Tibial Wedge Screw N/A LEGION Locking Set Screw N/A LEGION Tibial Wedge Lug 10, 15 mm LEGION Tibial Cone 18-30 mm, Short/Long LEGION Revision Tibial 9-24 mm x 120 mm Baseplate (Cemented) 9-24 mm x 160 mm LEGION Press-fit Stem Straight - 10-24 mm x 220mm Bowed - 10-24 mm x 220mm Bowed - 10-24 mm x 280 mm 10-20 mm x 120 mm LEGION Cemented Stem Straight 10-20 mm x 160 mm LEGION Short Stem Extension 10-14 mm x 80 mm LEGION Offset Coupler 2-6 mm LEGION Offset Coupler Angled N/A LEGION Male to Male Mini Coupler 2-6 mm LEGION Porous HA Tibial GENESIS II Tibial Bone Screw 15 – 50 mm Baseplate with Holes LEGION Porous HA Tibial PROFIX Metaphyseal Tibial Stem 16, 18, 20 mm Baseplate with Holes LEGION Porous HA Tibial GENESIS II Long Stem 100, 150mm Baseplate without Holes * Component must be used with the LEGION Femorals (CoCr and OXINIUM™) and Tibial Stem 61 Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Smith & Nephew representative or distributor if you have questions about the availability of Smith & Nephew products in your area. Smith & Nephew, Inc. www.smith-nephew.com 7135 Goodlett Farms Parkway Cordova, TN 38016 USA Telephone: 1-901-396-2121 Information: 1-800-821-5700 Orders and Inquiries: 1-800-238-7538 ©2022 Smith & Nephew, Inc. ™Trademark of Smith & Nephew. All rights reserved. All Trademarks acknowledged 02860 V3 71281978 REVB 11/22  Surgical Technique Table of contents Introduction........................................................................................................................................1 Precautions regarding surgical technique.........................................................................................2 Preoperative planning.......................................................................................................................3 Surgical technique.............................................................................................................................4 Explantation of the stem..................................................................................................................14 Postoperative treatment...................................................................................................................15 Sterilization.......................................................................................................................................15 Implants............................................................................................................................................16 Dimensions...................................................................................................................................... 17 Instruments......................................................................................................................................19 Note Bena The surgical technique described in this brochure is the procedure suggested by the authors for uncomplicated surgery. The surgeon must, however, decide which procedure is the most suitable and effective for each individual patient. e-IFU homepage:ifu.smith-nephew.com The following technique is for informational and educational purposes only. It is not intended to serve as medical advice. It is the responsibility of treating physicians to determine and utilize the appropriate products and techniques according to their own clinical judgment for each of their patients. For more information on the product, including its indications for use, contraindications, and product safety information, please refer to the product’s label and the Instructions for Use. Introduction The SL-PLUS™ MIA INTEGRATION-PLUS™ stem, also referred to as SL-PLUS MIA, has been in clinical use since 2007. The innovative design of the SL-PLUS MIA is based on the SL-PLUS by elimination of the trochanteric wing and retaining the successful biological meta-diaphyseal anchoring concept.1-7 The dual-tapered straight stem with its rectangular cross section helps to establish excellent primary and rotational stability in the cortical bone.3,6 The SL-PLUS MIA stem is designed to implant using minimally invasive surgical techniques as it preserves and protects the greater trochanter bone.* This may minimise the risk of fracture as a result of better trochanteric bone stability.4-5,8-10 The cementless SL-PLUS MIA range includes 14 standard stems with a CCD angle of 131° and 12 lateral stems with a CCD angle of 123°. All stems are coated with the INTEGRATION-PLUS open-pored titanium plasma/HA coating in the proximal area leading to accelerated and increased bone on-/in-growth.**6-7,11-12 *Compared to SL-Plus Primary **Compared to HA only coated stems and non-HA coated stems 1 Precautions regarding surgical technique Reliable fit of femoral ball heads on stem tapers The taper connection can only be reliably and firmly seated if the surface of the ball head cone and the surface and structure of the hip stem taper are completely intact. The disposable plastic cap protecting the stem taper from damage shall not be removed until the trial ball is attached. To ensure that the ball head performs as required, it is essential to take great care when attaching it to the stem taper: Clean and dry the neck taper with a clean, sterile cloth. Place the prosthetic femoral head on the neck taper and firmly impact with the femoral ball head impactor and a mallet several times. Never reuse a femoral ball head that has been impacted onto a stem cone and then removed. Restrictions on head/insert combinations • BIOLOX®forte/delta ceramic inserts must only be combined with BIOLOX®forte/delta ceramic ball heads. Compatible Devices/Devices used with: The surgeon must always ensure that the individual components of the total/partial hip arthroplasty are compatible. SL-PLUS™ MIA must not be combined with other manufacturer implants, unless the implant combination is described within this document, the SL-PLUS MIA IFU, or is listed in the compatibility matrix (lit. no. 04758) available on ifu.smithnephew.com. The compatibility matrix provides all femoral head combination options for SL- PLUS MIA relating sizes and material. Ball heads should only be combined with hip stems of identical taper dimensions. SL-PLUS MIA can be combined with all acetabular cup systems manufactured by Smith & Nephew Orthopaedics AG and Smith & Nephew Inc. taken into account any restrictions given by the relevant femoral head. Further, SL-PLUS MIA should always be implanted using Smith & Nephew Orthopaedics AG surgical instruments, unless these are commonly used in the operating room and/or described in this surgical technique. All liability is excluded for the unauthorised use of third-party products. Note: - SL-PLUS MIA must not be combined with femoral ball heads made of stainless steel - Size 01 SL-PLUS MIA standard stem must not be used in combination with femoral ball heads with neck length +16 Femoral ball head revisions For the revision of a femoral ball head, apply the following: • The corresponding insert has to be revised as well. • Replacement only by a metal ball head or a special ceramic revision femoral ball head featuring a metallic taper adaptor (BIOLOX® OPTION). Do not assemble a standard ceramic head on a used taper; the ceramic head may fracture from irregularities on the femoral component taper. • In the case of a revision involving a fractured ceramic component, femoral ball head and insert have to be revised. Remove all loose identifiable fragments and thoroughly irrigate and lavage the operative site. A special ceramic revision femoral ball head coupled with a metallic taper adaptor should be used if the femoral taper is intact. Metal or OXINIUM◊ femoral ball heads with a polyethylene insert shall not be used for revising fractured ceramic components. In case the taper is damaged or no appropriate ceramic revision femoral ball head is available, the femoral stem must be revised to provide a suitable femoral taper to attach a new ceramic ball head. 2 Preoperative planning Preoperative planning is essential to determine the correct orientation and size of implant. AP and axial X-rays are required for this purpose. The offset and neck length to be achieved with the prosthesis are determined with the aid of X-ray templates. Preoperative planning requires: x • X-rays x • Templates for the acetabular component and the stem or • Digital templates for the acetabular component and the stem The following acetate X-ray templates are available for SL-PLUS™ MIA: Item No. Description 2202 SL-PLUS MIA X-ray templates Standard / Lateral 1.15 Today, digital templating is the new standard in many institutions. Smith & Nephew is supporting a number of third party digital pre-operative planning tools. To determine the entry point in the medullary canal, the surgeon is advised to draw the femoral axis on the AP radiograph and extend this proximally. This line indicates how far laterally the box chisel needs to be placed to open up the medullary canal, thus facilitating identification of the lateral entry point at operation. It is also helpful to define the position of the stem within the canal. The distance x from the shoulder of the stem to the greater and lesser trochanter is measured and can serve as an additional leg length check. Note X-ray templating is not as reliable for determining implant sizing in revision cases as they are in planning for primary implantations and can therefore only provide an approximate estimate of the actual stem size required. Warnings and precautions SL-PLUS MIA implants must not be implanted with cement. Please contact your local Smith & Nephew representative or distributor to order X-ray templates or in case of any other product related question. 3 Surgical technique Position of the patient and approach For the purpose of this surgical technique, the anterolateral, minimally invasive approach is chosen with the patient in the supine position. Whether an anterolateral, lateral, posterolateral or posterior approach is used is at the surgeon’s discretion. The skin incision and muscle detachment depend on the selected approach. All implants and instruments suit conventional or minimally invasive surgical techniques. Capsular incision and dissection Perform a blunt dissection between the tensor fasciae latae and the gluteus medius/minimus from the lateral side to expose the femoral neck. One sharp and one blunt Hohmann retractor are placed laterally and medially respectively. The curved rectus tendon is exposed, undermined, divided and released from its attachment to the capsule. The third retractor is placed between the ventral joint capsule and the overlying muscles (curved rectus tendon and the ileopsoas muscle). The femoral neck is then exposed via an H-shaped incision of the joint capsule: • longitudinal incision, as far medially as possible, from the acetabular rim to the intertrochanteric line • proximal transverse incision of the acetabular labrum from approx. the nine o’clock to the three o’clock position • distal transverse incision extending along the intertrochanteric line 4  After the wing-like opening of the joint capsule, the dissection of the capsule can be continued by extending the distal incision along the intertrochanteric line in the direction of the lesser trochanter and the proximal incision medially and/or laterally. Two blunt Hohmann retractors are positioned inside the joint. Problematic osteophytes on the acetabular rim are removed. The technique selected by the surgeon for the neck resection (single or double osteotomy) depends on the patient (coxa vara/valga). Capsular release In order to facilitate alignment of the stem, the surgeon switches the leg to the “Figure of 4” position and performs an additional release of the posterior capsule. Now a retractor is placed between the capsule and the gluteus muscle holding the leg in a 10-20° abducted position. This facilitates the placement of the retractor and gives access to the lateral and cranial part of the capsule. In that way this part of the capsule should be released or resected. The leg is hyperextended, adducted approximately 30–40° and externally rotated by 90°. The leg being operated on is placed under the other leg in a “Figure of 4” position. Alternatively, the other leg is lowered and the leg being operated on is placed on top. The proximal femur is mobilized with two retractors, a lateral trochanter retractor and a second retractor on the medial side of the femoral neck. Capsular releases must be performed in the direction of both the lesser trochanter and the trochanteric fossa to the tip of the trochanter. Optionally, it can also be performed on the caudal rim of the acetabulum. 5  The cup is then implanted according to the corresponding surgical technique. Stem Preparation In very muscular or obese patients, patients with a valgus femoral neck, or in cases where the proximal femur sits deep to the skin surface, further release of the posterior capsule or release of the piriformis tendon may be necessary to allow Inferior gemellus m. adequate mobilization of the femur prior to preparation of the Internal obturator m. implantation site. Superior gemellus m. Piriformis m. Access to the medullary canal The box chisel (75006419/41000029) is placed close to the posterior cortex at the resection level. The box chisel is introduced in alignment with the femoral axis and a small square block of bone is removed. If, after the neck resection, the box chisel is not used to expose the canal, splitting of the trochanter may occur during rasp insertion. Do not impact the box chisel too deeply. The MIA curved rasp facilitates opening of the diaphyseal medullary cavity. Removal of the intramedullary fat by suction to avoid fat embolism. Further opening of the diaphyseal medullary cavity and probing of the diaphysis with a corresponding awl are recommended. 6  Use of the MIA guide rasp The aim of the MIA guide rasps is to ensure easier alignment Medial of the rasping bed, thereby preventing a varus implant seating. The MIA guide rasp should be introduced with the desired degree of anteversion, matching the planned rotation of the stem. The rasp depth can be checked by means of the line markings 123456 on the stem. These markings correspond to the shoulder level Markings on implant shoulder of the respective SL-PLUS™ MIA implant size. During the rasping operation, care should be taken to restrict the depth of insertion of the MIA guide rasp to around one or two sizes smaller than the planned implant size. As soon as cortical contact is achieved the guide rasp should not be driven any further. An optional MIA guide rasp, size 01-3, is available for small stem sizes of 01 or 0. When mounting the rasp on the slap hammer or rasping machine, ensure that the side marked “MEDIAL” is correctly oriented. If the medial and lateral sides are inadvertently reversed, the rasp handle may strike the medial aspect of the greater trochanter, forcing the rasp out of its planned neutral alignment. Broaching of the femur The rasp cuts longitudinal grooves in the femoral cortex. The goal is to achieve extensive surface area contact to provide cortical support for the implant. By gradually increasing the depth of rasping within the medullary cavity, the area of cortical contact increases, along with the resistance to the advance of the rasp. As soon as the rasp is fully engaged within cortical bone, the pitch of the hammer blows rises. The critical resource for checking the correct size is the preoperative planning with the X-ray. Preparation of the bone bed up to implants of size 4 starts with a size 01 rasp. For implants of size 5 and above, a size 1 rasp can be used initially. Important Since the first rasp determines the position of all the following rasps, its orientation is critical for exact positioning of the stem. 7  For correct alignment, the rasp is inserted along the anatomical axis of the stem. If the operator deviates from this axis there is a risk of subsequent varus positioning of the stem in the femur. The mountable MIA detachable rasps are used to create an implantation site of the correct size and alignment for the femoral implant, as described below. Adapters with differing offsets are available to accommodate the selected surgical approach and/or patient size. Please refer to the instrument sets on page 21 and 22. All modular adapters can be connected to the slap hammer or the MIA Rasping Machine (IMT Woodpecker) or the modular knock plate (75000642/21000378). At the start of the rasping process, the depth of the rasp must be checked to ensure that it is not inserted too deeply. It is Bone loss in calcar arch extremely important to understand that the osteotomy is unrelated to the final position of the implant. Because of the initially reduced rasp resistance, there is a tendency for surgeons to insert the smaller rasps too deeply into the femur. This will result in excessive enlargement of the implantation site and lead to gaps on the medial aspect between the bone and the final implant. 8  The subsequent rasp is introduced into the cavity until resistance is felt. The rasp is then driven laterally and distally into the femur using the (slap) hammer or the rasping machine. This process is repeated with sequential rasp sizes until an adequate depth is achieved for the desired implant size. If the double offset adapters are used, care should be taken to ensure that these instruments are used on the corresponding side of the patient. The rasp is introduced into the cavity along a slightly arc-shaped path. Attention should be paid to the anteversion and varus/valgus alignment of the slap hammer or the rasping machine with respect to the femoral axis. Insertion of the rasps in a varus inclination involves the risk of perforation and/or fracture of the lateral cortex of the femur. If rasping is carried out using the slap hammer or the MIA Rasping Machine, the weight of these instruments helps ensure the precise longitudinal alignment of the rasp within the femur. It is important that lateral pressure is continuously applied to the rasping machine to ensure that the rasp moves in line with the axis of the canal and does not seat in a varus position. 9  The shoulder of the rasp corresponds to the shoulder height of the implant and should correspond to the preoperatively determined distance to the greater trochanter (marked x). If the greater trochanter is not present anymore, the lesser trochanter x can be taken instead. Only in rare cases does the planned prosthesis size not correspond to the size rasped at operation. If there is a discrepancy of two or more sizes, the rasp may not have reached the necessary depth because of incorrect angulation or the presence of an obstacle in the canal. In these cases the prosthesis would be too small and stable cortical anchorage would not be ensured in the long term. If doubt exists, intraoperative radiography or fluoroscopy is necessary so that the obstruction can be assessed. If the preplanned implant size goes too deep into the femoral canal, a fracture (fissure) should be excluded by intraoperative radiography or fluoroscopy. Once the optimum size and stability of the rasp and its height position are achieved, the offset adapter is removed from the mounted detachable rasp. 10  Trial Reposition The neck module is attached to the detachable rasp by hand. Standard neck modules are available for detachable rasp sizes 01–0, 1–6 and 7–12. Matching “lateral” neck modules are available for detachable rasp sizes 1–6 and 7–12. It is important to ensure that the neck module fits flush with the detachable rasp and that it clicks into position. Trial Reposition The selected trial ball head can either be fitted to the neck module in advance or in situ. Ideally fitting of a M/+4 or L/+8 trial ball head is recommended to leave room for up-/down- sizing on the final stem. The joint is reduced and the leg length, soft tissue tension and range of motion are checked. During the initial operations, it is recommended that the surgeon obtain AP and lateral intraoperative radiographs (image intensifier) to verify the position and size of the rasp in both planes. If necessary the trial ball head and/or the neck module (standard or lateral) should be replaced until a satisfactory result is achieved. If luxation is still possible even though the lateralized modular neck is used and the rasp is securely seated, check if the next sized stem should be used. This then generally protrudes further proximally out of the femoral bone compared to the smaller size and can therefore lead to leg lengthening. The patient should be made aware of this risk before the surgery. 11 The neck module can either be removed manually from the detachable rasp or with a Kocher retractor. The rasp adapter is connected to the detachable rasp. The connected rasping machine or the slap hammer is used to remove the detachable rasp. Removal of the rasp, as with its introduction, must be performed along a curved arc to minimize disturbance of the bone bed and to avoid fractures in the vicinity of the trochanter. Implantation of the stem The stem of the correct size is introduced manually as deep as possible into the canal. The SL-PLUS™ MIA stem is then seated with the MIA stem impactor (75007255/600621), using appropriately measured strokes to minimize the risk of femoral fractures. The Ti/HA coating leads to a total oversize of 0.7 mm and, particularly if hard bone is present, can prevent the implant from being inserted as deeply as the rasp. In this case, it is advisable to recheck the leg length, soft tissue tension and range of motion with the trial ball head. This oversize is not usually relevant for clinical purposes and can be offset with a shorter ball head. Otherwise, the implant bed must be enlarged accordingly with the last rasp. The protective cap remains mounted on the cone during impaction. Please note It is not sufficient to press the stem in solely by hand. It is not permitted to impact the stem deeper than the prepared bony bed or to correct the position once the stem is in the cone bed as this would inevitably split the femoral stem. It is recommended to recheck the leg length, soft tissue tension and range of motion with the trial ball head. 12  Ball head introduction Remove the plastic taper protection. Before positioning the ball head, carefully wash the stem cone with water and then dry. The ball head is then fitted by screwing it lightly into place. The ball head is firmly impacted using the ball head impactor (75002160/110242). The joint is then reduced, manipulated and retested to ensure proper functioning. Note Please carefully read the chapter “Reliable fit of femoral ball heads on stem tapers” on page 2. Ceramic heads must never be impacted using a metal instrument. Each femoral stem has a standard 12/14 cone for coupling with OXINIUM™, ceramic or CoCr ball heads supplied by Smith & Nephew Orthopaedics AG or Smith & Nephew Inc. Wound closure Insert Redon drains and close the wound. Position the leg in slight abduction. 13 Explantation of the stem The SL-PLUS™ MIA stem can be extracted using the M6 extraction screw (75002165/110249). In case of difficulty, an extractor block secured with the M8 extraction screw is also available. Both extraction screws, M6 and M8, can be used in connection with either the slap hammer or the rasping machine. Please note Ensure that the extraction screw is inserted axially. The removal of a well osseointegrated stem should be done by the following four steps: 1.  reak the bone bridges in the proximal (Ti-/HA-coated) part B of the stem by using a thin flat chisel. 2. Make a short cut in the cortical bone with a thin saw blade at the distal end of the stem. Both ends of this cut should be drilled with a Ø4.0mm drill to avoid fissure following this cut. This cut should be placed in the ventral - lateral part of the femur corticalis. 3. Spread the bone edges of this cut carefully from the implant using a chisel with gentle wedge action. Doing so, you will break the bone bridges between the distal end of the implant and the surrounding bone. 4. Try to remove the implant stem with the appropriate extrac- tion tools as described above. Note For additional stem removal tools, consider Smith & Nephew’s RENOVATION™ Implant Removal System, lit no 7138-0701. 14 Postoperative treatment The postoperative treatment depends on the patient’s age and general state of health. The operated leg may be immediately weight bearing. For 48 hours a splint (foam) in slight abduction is recommended. The use of crutches can be helpful during the first days. The use of antibiotics and thrombosis prophylaxis as well as suture removal are at the surgeon’s discretion. Serious incidents related to any Smith & Nephew medical device should be reported to Smith & Nephew ([email protected]) and to the competent authority of the country in which the user and/or patient is established. Sterilization Implants All the implants described in this Surgical Technique are sterile when they are delivered by the manufacturer. Resterilization is not allowed. Instruments Surgical instruments and trials are not sterile when they are delivered. They are to be cleaned, inspected and sterilized before use as described in the guide “Processing (cleaning, disinfection and sterilization) of instruments from Smith & Nephew Orthopaedics AG” (Lit. No. 03389). Sterilization must also be conducted in accordance with the legal regulations and guidelines applicable in the country of use. A separate guide is available for the MIA Rasping Machine (Woodpecker, 75004683/800-09-001) from its manufacturer IMT: please, refer to “Operation Manual Woodpecker” on https://www.imt-medical.com/handling- and-maintenance/. 15 Implants SL-PLUS™ MIA INTEGRATION-PLUS™ Cementless Stem Material: Ti-6Al-7Nb ISO 5832-11, Cone 12/14 With Ti-plasma/hydroxyapatite coating proximally: Standard Stem CCD 131° Lateral Stem CCD 123° SAP No. Art. No. Size SAP No. Art. No. Size 75000172 11000422 01 - - - 75000173 11000423 0 - - - 75000174 11000424 1 75000186 11000436 1 75000175 11000425 2 75000187 11000437 2 75000176 11000426 3 75000188 11000438 3 75000177 11000427 4 75000189 11000439 4 75000178 11000428 5 75000190 11000440 5 75000179 11000429 6 75000191 11000441 6 75000180 11000430 7 75000192 11000442 7 75000181 11000431 8 75000193 11000443 8 75000182 11000432 9 75000194 11000444 9 75000183 11000433 10 75000195 11000445 10 75000184* 11000434 11 75000196* 11000446 11 75000185* 11000435 12 75000197* 11000447 12 *Outlier size (optional) * Outlier size (optional) Demo Implants SAP No. Art. No. Size Description 75023398 91000428 5 SL-PLUS™ MIA INTEGRATION-PLUS Standard 75023399 91000440 5 SL-PLUS MIA INTEGRATION-PLUS Lateral 16 Dimensions All dimensions in mm Specifications Neck Height Standard Size Stem Stem M/L CCD CCD Size XS/–3 S/+0 M/+4 L/+8 XL/+12 XXL/+16 length I length II width angle angle Standard Lateral 01 128 109 26 131 01 17 19 21 24 27 32 0 132 113 27 131 0 18 19 22 25 27 33 1 137 117 28 131 123 1 18 20 23 25 28 33 2 141 121 29 131 123 2 19 21 23 26 29 34 3 145 124 30 131 123 3 20 21 24 27 29 35 4 150 128 32 131 123 4 20 22 25 27 30 35 5 154 132 33 131 123 5 21 23 26 28 31 36 6 159 136 34 131 123 6 22 24 26 29 32 37 7 163 140 35 131 123 7 23 25 27 30 32 38 8 168 144 37 131 123 8 24 25 28 31 33 39 9 173 148 39 131 123 9 24 26 29 32 34 39 10 178 152 40 131 123 10 25 27 30 33 35 40 11 183 157 42 131 123 11 26 28 31 34 36 41 12 188 162 44 131 123 12 27 29 32 35 37 42 Offset Standard Lateral Size XS/–3 S/+0 M/+4 L/+8 XL/+12 XXL/+16 Size XS/–3 S/+0 M/+4 L/+8 XL/+12 XXL/+16 01 28 30 33 36 39 42 1 35 38 41 44 48 51 0 29 31 34 37 40 43 2 37 39 42 46 49 52 1 30 32 35 38 41 44 3 38 40 44 47 50 54 2 31 33 36 39 42 45 4 39 42 45 48 52 55 3 32 34 37 40 43 46 5 41 43 47 50 53 57 4 33 35 38 41 44 47 6 42 45 48 51 55 58 5 34 37 40 43 46 49 7 44 46 50 53 56 60 6 36 38 41 44 47 50 8 45 48 51 55 58 61 7 37 39 42 45 48 51 9 47 50 53 56 60 63 8 38 41 44 47 50 53 10 49 51 55 58 61 65 9 40 42 45 48 51 54 11 51 53 56 60 63 66 10 41 43 46 49 53 56 12 52 55 58 61 65 68 11 43 45 48 51 54 57 12 44 46 50 53 56 59 Neck length Standard Lateral Size XS/–3 S/+0 M/+4 L/+8 XL/+12 XXL/+16 Size XS/–3 S/+0 M/+4 L/+8 XL/+12 XXL/+16 01 17 20 24 28 32 36 1 26 29 33 37 41 45 0 18 21 25 29 33 37 2 27 30 34 38 42 46 1 19 22 26 30 34 38 3 28 31 35 39 43 47 2 20 23 27 31 35 39 4 29 32 36 40 44 48 3 21 23 27 31 35 39 5 30 33 37 41 45 49 4 22 24 28 32 36 40 6 32 34 38 42 46 50 5 22 25 29 33 37 41 7 33 36 40 44 48 52 6 23 26 30 34 38 42 8 34 37 41 45 49 53 7 24 27 31 35 39 43 9 35 38 42 46 50 54 8 25 28 32 36 40 44 10 37 40 44 47 52 56 9 26 29 33 37 41 45 11 38 41 45 49 53 57 10 27 30 34 38 42 46 12 39 42 46 50 54 58 11 29 31 35 39 43 47 12 30 33 37 41 45 49 17  Offset Lateral XXL/+16 Offset Standard XL/+12 M/L width L/+8 M/+4 Neck height S/+0 XS/-3 Neck length Standard Neck length Stem length I CCD angle Lateral Stem length II 18 Instrument Set SL-PLUS™ MIA Basic Set Set No. SAP/Art. 75200838/0942010 SAP No. Art. No. Description Size 75002198 110450 Case Basic Instruments 1/4 75007661 990019 Easy Tray Lid Plastic 1 75002319 110901 Slap Hammer 2 75002320 110902 Extractor Block 3 75002325 110911 Extraction Screw M8 4 75002165 110249 Extraction Screw M6 5 75002160 110242 Ball Head Impactor 6 75007255 600621 MIA Stem Impactor 7 75004495 21000138 MIA Curved Rasp 8 75006420 41000030 MIA Guide Rasp 1-6 9 75100839* 75100839 Trial Ball Head 22 S/+0 75100840 75100840 Trial Ball Head 22 M/+4 75100841 75100841 Trial Ball Head 22 L/+8 75100842* 75100842 Trial Ball Head 22 XL/+12 75100843* 75100843 Trial Ball Head 28 XS/-3 75100844 75100844 Trial Ball Head 28 S/+0 75100845 75100845 Trial Ball Head 28 M/+4 75100846 75100846 Trial Ball Head 28 L/+8 75100847 75100847 Trial Ball Head 28 XL/+12 75100848 75100848 Trial Ball Head 28 XXL/+16 75100849* 75100849 Trial Ball Head 32 XS/-3 75100850 75100850 Trial Ball Head 32 S/+0 75100851 75100851 Trial Ball Head 32 M/+4 75100852 75100852 Trial Ball Head 32 L/+8 75100853 75100853 Trial Ball Head 32 XL/+12 75100854 75100854 Trial Ball Head 32 XXL/+16 75100855* 75100855 Trial Ball Head 36 XS/-3 75100856 75100856 Trial Ball Head 36 S/+0 75100857 75100857 Trial Ball Head 36 M/+4 75100858 75100858 Trial Ball Head 36 L/+8 75100859 75100859 Trial Ball Head 36 XL/+12 * Optional Instruments Optional: SAP No. Art. No. Description Size 75210292 75210292 SET 40 mm Trial Ball Head XS/-4 to L/+8 75210293 75210293 SET 44 mm Trial Ball Head XS/ 1-6 to L/+8 75000645 21000397 MIA Curved Rasp 45° 75004615 21000265 MIA Start Rasp 75004683 800-09-001 MIA Rasping Machine (IMT Woodpecker)* *Manufacturer: IMT Integral Medizintechnik AG, Haldenstrasse 5, 6006 Luzern, Switzerland 19  8 7 1 4 3 9 2 5 6 20 SL-PLUS™ MIA Trial Rasps Set Set No. SAP 75210409 Set No. SAP No. Description Size 75007312 600930 MIA Instrument Case 75007661 990019 Easy Tray Lid Plastic 1 75004481 21000123 MIA Detachable Rasp 01 75004482 21000124 MIA Detachable Rasp 0 75004483 21000125 MIA Detachable Rasp 1 75004484 21000126 MIA Detachable Rasp 2 75004485 21000127 MIA Detachable Rasp 3 75004486 21000128 MIA Detachable Rasp 4 75004487 21000129 MIA Detachable Rasp 5 75004488 21000130 MIA Detachable Rasp 6 75004489 21000131 MIA Detachable Rasp 7 75004490 21000132 MIA Detachable Rasp 8 75004491 21000133 MIA Detachable Rasp 9 75004492 21000134 MIA Detachable Rasp 10 75004493* 21000135 MIA Detachable Rasp 11 75004494* 21000136 MIA Detachable Rasp 12 2 75004603 21000253 MIA Modular Neck for Detachable Rasp Std 01–0 75004604 21000254 MIA Modular Neck for Detachable Rasp Std 1-6 75004605 21000255 MIA Modular Neck for Detachable Rasp Std 7-12 3 75004606 21000256 MIA Modular Neck Detachable Rasp lat. 1–6 75004607 21000257 MIA Modular Neck Detachable Rasp lat. 7-12 4 75006419 41000029 MIA Box Chisel 5 75009352* SYS251374 Trochanter Retractor *Optional Instruments Optional Rasp Adapters Set No. SAP No. Art No. Description Size 75200166 75007307 600920 MIA Offset Adapter 25mm 75200168 75007308 600921 MIA Offset Adapter 40mm 6 75200169 75007309 600922 MIA Offset Adapter 10mm 7 75007310 600923 MIA Double Offset Adapter Left 17/13mm 75200171 8 75007311 600924 MIA Double Offset Adapter Right 17/13mm 75004612 21000262 MIA Double Offset Adapter Left 60/25mm 75210202 75004613 21000263 MIA Double Offset Adapter Right 60/25mm 75210372 75004614 21000264 MIA Offset Adapter 45° 75210406 75004468 21000107 MIA Offset Adapter with Plate 25mm 75000642 21000378 Knock Plate 21  4 5 OPTIONAL 1 OPTIONAL OPTIONAL 3 2 7 6 8 22 Notes References 1. Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) 2021. Automated Industry Report (AIRS) ID 4082 - SL-PLUS INTEGRATION PLUS MIA Stem (Combined Standard and Lateral). Adelaide. 2. Affatato S, Comitini S, Fosco M, Toni A, Tigani D. Radiological identification of Zweymüller-type femoral stem prosthesis in revision cases. Int Orthop. 2016;40(11):2261-2269. 3. Smith+Nephew 2019. Clinical Obserservation Study of the Hydroxylapatite-Coated SL-PLUS™ MIA Hip Stem. Internal Report. Study D10080-2. 4. Swiss National Joint Registry (SIRIS) 2021. SIRIS Industry Report for Smith+Nephew SL-PLUS INTEGRATION PLUS MIA Stem. Bern. 5. Endoprothesenregister Deutschland (EPRD) 2021. Data Summary for SL-PLUS INTEGRATION MIA Stem (H1.5 Femoral Component). Berlin. 6. Reiner T, Sonntag R, Kretzer JP, et al. The migration pattern of a cementless hydroxyapatite-coated titanium stem under immediate full weight-bearing—a randomized controlled trial using model-based rsa. J Clin Med. 2020;9(7):1-10. 7. Tanaka A, Kaku N, Tabata T, Tagomori H, Tsumura H. Comparison of early femoral bone remodeling and functional outcome after total hip arthroplasty using the SL-PLUS MIA stem with and without hydroxyapatite coating. Musculoskelet Surg. 2019;104(3):313-320. 8. Junk-Jantsch S, Pflüger G. MIS and the Demands on Bearing Couples. In: Bioceramics and Alternative Bearings in Joint Arthroplasty: Springer; 2007. 9. Pflüger G, Junk-Jantsch S, Schöll V. Adaptation of the Zweymüller stem (SL-PLUS® stem) for minimally invasive hip surgery: Experiences after 1½ year. EFORT-Poster. 2007. 10. Brandenberg J, Steiger U. Der SL-PLUS-MIA-Schaft-ergebnisse nach 1000 Implantationen; The SL-Plus-Mia-stem-results after 1000 implantations. OUP. 2012;1(5):208. 11. Strnad Z, Strnad J, Povysil C, Urban K. Effect of plasma-sprayed hydroxyapatite coating on the osteoconductivity of commercially pure titanium implants. Int J Oral Maxillofac Surg. 2000;15(4):483-490. 12. Zheng X, Huang M, Ding C. Bond strength of plasma-sprayed hydroxyapatite/Ti composite coatings. Biomaterials. 2000;21(8):841-849. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Smith+Nephew representative or distributor if you have questions about the availability of Smith+Nephew products in your area. www.smith-nephew.com Manufacturer Smith & Nephew Orthopaedics AG ™Trademark of Smith & Nephew. Theilerstrasse 1A All trademarks acknowledged 6300 Zug ©2024 Smith & Nephew Supporting healthcare professionals for over 150 years Switzerland 31156-en V2 11/24 0123  Surgical Technique INTENDED FOR NON-US USE ONLY Design surgeon list Smith & Nephew thanks the following surgeons for their participation as part of the R3™ system design team: Robert Barrack, MD John L. Masonis, MD St. Louis, Missouri OrthoCarolina Hip & Knee Center Robert Bourne, MD Charlotte, North Carolina London Health Sciences Center London, Ontario, Canada Henrik Malchau, MD Associate Professor, Harvard Medical School Jonathan Garino, MD Co-Director, The Harris Orthopaedic Biomechanics University of Pennsylvania and Biomaterials Laboratory School of Medicine Massachusetts General Hospital Philadelphia, Pennsylvania Boston, Massachusetts Wayne M. Goldstein, MD Michael Ries, MD Clinical Professor of Orthopaedics University of California University of Illinois at Chicago San Francisco, California Illinois Bone and Joint Institute Chicago, Illinois Cecil Rorabeck, MD Professor of Orthopaedic Surgery Richard Kyle, MD University of Western Ontario Minneapolis, Minnesota London, Ontario, Canada Stephen J. McMahon, MB, BS, FRACS(Orth), FA(Orth)A Senior Lecturer Monash University Malabar Orthopaedic Clinic Melbourne, Australia Nota Bene: The technique description herein is made available to the healthcare professional to illustrate the authors’ suggested treatment for the uncomplicated procedure. In the final analysis, the preferred treatment is that which addresses the needs of the patient. For more information on the products in this surgical technique, including indications for use, contraindications, effects, precautions and warnings, please consult the products’ Instructions for Use (IFU).  Short technique 1. Preoperative planning 4. Shell insertion 2.Acetabular reaming 5. Acetabular screw insertion 3.Acetabular trialing 6. Acetabular poly liner insertion Preoperative planning Preoperative X-Rays should include an A/P of the pelvis centered over the symphysis and an A/P and lateral of the affected hip. Templating can be done on the affected side, but it is important that the contralateral hip also be templated to verify the size. To ensure a congruent fit, the acetabular component should be medialized to the medial aspect of the acetabulum, as indicated by the teardrop. The center of rotation also should be marked for subsequent reference. Surgical tips: • To minimize the need of assistance, each of the acetabular retractors can be tied directly to a Charnley retractor. • Dividing the transverse acetabular Acetabular exposure ligament will allow reaming to begin inferiorly, preventing the tendency of the reamer to migrate superiorly. Complete exposure of the acetabulum is required, • Removal of soft tissue and overhanging osteophytes from the regardless of the type of approach. Use the foveal notch aids visualization of the approach with which you are most familiar and quadralateral plate and the depth that achieve the best surgical results. the acetabulum should be reamed. First, resect the acetabular labrum and place a blunt retractor anteriorly. After identifying the transverse acetabular ligament, place a blunt retractor around the inferior margin of the acetabulum. Depending on the exposure, a third retractor can be placed posteriorly following the excision of the labrum. Remove all overhanging soft tissue and osteophytes in order to visualize the entire acetabular socket. The acetabulum should be medialized to restore the normal center of hip rotation. 4 Acetabular reaming Select an acetabular reamer that is considerably Surgical tips: smaller than the templated size of the cup. • Each successive reamer must be fully Generally, reaming 6-8mm lower than the seated within the acetabulum. Failure templated size is suitable. to do so will result in lateralization of the trial and exposure of the porous Position the initial reamer in a vertical direction coating. If lateralization occurs, go back (1) to ensure the reamer is taken down to the to a smaller reamer and begin again, medial wall. checking each size to ensure that the reamers are fully seated. Direct the second reamer and all subsequent • Increasing the reamer size by 2mm reamers in approximately 45° of abduction is recommended, although in smaller and 20° of anteversion for final position of the patients 1mm increments may be acetabular component (2). preferred. • Mark the medial wall with an Preserve subchondral bone to provide good electrocautery prior to using the last support for the prosthesis. This might mean reamer. If the last reamer does not the reamer will not be medialized all the way to remove the mark, repeat reaming, the inner wall. One might suggest leaving some dropping back a size if necessary. remaining subchondral bone and removing the medial bone that is osteophyte and is covering fatty tissue. Instrument tips: Frequently palpate the posterior and anterior walls of the acetabulum during the reaming • The acetabular reamer has an open process as these walls will determine the largest back, which helps visualize reaming and acetabular size that can be accommodated. Avoid allows easy access to bone chips. This style of reamer is hemispherical and allowing the reamer to drift posteriorly where the when fully seated it should be covered bone might be less dense and the path of least by the rim of the acetabulum. resistance for the reamer. • Gently rock reamer handle back and To press-fit an R3™ acetabular shell the acetabulum forth approximately 5° for last size used can either be under-reamed by 1mm or may be only to ensure rim is accurate for the desired press-fit. reamed line-to-line depending on the bone quality and size of the acetabulum. 5 Acetabular trialing After preparing the acetabulum, the trial shell Surgical tip: should be inserted to verify size and position of • The bone at the edge of the trial shell the cup. The surgeon should note the appropriate can be marked with an electrocautery to orientation of the acetabular trial to position the help in final component positioning. cup correctly. A trial liner insert cannot be inserted into a trial Instrument tip: shell for trial reduction. • The trial shells are the exact size If trial reduction using a trial insert is desired specified. They can be used to assess the accuracy of reaming or can be at this time, then the preparation of the femur press-fit into the acetabulum if using a should occur up until the trial reduction stage. larger size than the final reamer. The surgeon then has the option of inserting a trial acetabular liner (preferred) in the acetabular implant for subsequent leg length, offset and stability assessments or the real acetabular insert. 6 Acetabular shell insertion Select the appropriate acetabular implant, attach the shell to the cup positioner/impactor and insert it into the acetabulum. Surgical tips: Rotate the X-Bar shaft so that it is in line with the liner removal slot. For the THREE HOLE cup, this • The change in pitch that occurs as the shell is seated against the medial wall positions the three holes in the superior direction. is often audible. A depth gauge can be When implanting a MULTI HOLE shell, future access inserted through the screw holes and to the liner removal slot should be considered. apex hole to determine the adequacy of shell seating. Position the X-Bar so that the vertical bar is • Close attention should be paid to initial perpendicular to the long axis of the body and the positioning of the R3 shell. However, the appropriate crossbar (left or right) aligns with the use of the slap hammer may be helpful long axis of the body. in extracting the shell for repositioning. Firmly tap the inserter with a mallet until the cup is fully seated. Gently toggle the impactor handle to assess the stability and contact of the shell. Instrument tips: Remove the X-Bar, then disengage the impactor • The plastic tip on the cup impactor is handle and look through the impactor hole to removable for cleaning, or replacement if judge the distance between the medial wall and damaged. the shell. • The X-Bar references 45° of abduction and 20° of anteversion . If the cup is firmly seated, there should be no gap between the shell and the medial wall and no apparent movement in the component. Specific to shells for R3™ acetabular ceramic liners: Proper range of motion is critical for implant longevity. If any repositioning of the shell is required, it should only be performed using the shell positioner. Any use of a punch, osteotome or other instrument on the shell’s rim could result in damage to the taper section and compromise the integrity of the shell and ceramic liner mating and lead to liner fracture. It is important to protect the shell’s rim and inner taper from any damage during implantation. 7 Acetabular screw insertion Screw fixation is simple, fast and the most Surgical tip: common method of assuring additional fixation. • Screws have been shown to be a Acetabular screws work in compression, which reliable method of assuring fixation; allows the shell to fully seat in the acetabular however, it is important to avoid cavity. neurovascular complications by proper screw placement, avoiding the anterior/ For screw fixation, each screw hole must be superior or anterior/inferior quadrants. predrilled. Using the variable angle drill guide, adjust the angle of the tip to align with the selected screw hole and press firmly in the shell. After drilling the hole, use the depth gauge to verify appropriate screw length(s). Use the screw forceps to hold the screw. Attach the ball-joint or flexible screwdriver shaft to the end of the screw. Then introduce the screw into the hole and screw it into place using the ratcheting screwdriver handle. Make sure the screw is fully seated within the screw hole so that it will not impinge on the acetabular shell/liner. 8 R3™ Acetabular Liner insertion A trial reduction should be performed with the final Surgical tips: shell and broach in place to appropriately assess • Running a finger around the head length, stem offset, liner style and position. circumference of the shell and a visual With XLPE liners, use of ‘skirted’ modular heads check will help determine if the liner is should be avoided when possible to maximize flush with the shell face. range of motion. • The XLPE liner requires an impaction force between 60 and 120 pounds, Before inserting the R3 acetabular liner, lavage increasing with the diameter of the shell. any unused holes and insert the hole covers, if desired. Using the angled hole cover inserter, • The XLPE liner can be removed and repositioned once without compromising place screw hole covers over any remaining screw the locking mechanism of the liner. To holes and then impact with the peg impactor. remove R3 liners, insert the liner removal Cover the apex hole with the threaded hole cover. tool fully into the removal slot and pry or Using the straight screwdriver, screw in the hole impact the liner loose. cover until it stops and is flush with the inner diameter of the shell. For XLPE liner insertion, screw the appropriate Instrument tips: sized liner impactor head on the end of the cup impactor handle and ensure that the tabs on the • The liner trials are designed with flexible liner are aligned with the indentions in the shell. locking tabs around the periphery that Ensure all soft tissue and osteophytes have been is a quick-snap design. Align tabs with indentions and snap into position. removed from the periphery of the shell to avoid Do not force trial. The trial liners are interference with the liner lock. removed with the trial liner removal tool via the removal slot at the apex of the Wipe the shell ID with a lap sponge or gauze trial liner and a clockwise twist of the until clean and dry. Press the liner impactor removal tool. firmly until liner is partially locked. Then use light, repetitive impacts with the mallet until the liner is fully seated. Inspect the liner/shell interface for proper seating. The liner should sit flush with the face of the shell. 9 R3™ Acetabular Liner insertion continued R3 Hard Bearing insertion R3 Hard Bearings come preassembled with a disposable single-use Hard Bearing Alignment Guide. The liner/alignment guide assembly is then introduced by hand and sits flush on the face of the shell. The liner must be checked for proper orientation. Verification of proper liner seating in the shell should be confirmed by both a visual check to see that the insertion ring is sitting on the shell face and a manual check with the fingers to feel that the ring does not rock on the face of the shell. Do not impact the liner if it is not oriented Surgical tip: properly, as this can damage the shell and/or • It may prove helpful to rotate the liner/ locking mechanism. Once orientation has been guide slightly to ensure soft tissues and osteophytes are clear. confirmed, impact the liner into place using the appropriate sized liner impactor head placed on the shell positioner/impactor. Once impacted, the alignment guide will disengage onto the shell positioner/impactor and should be removed at that time.* * Cautionary Statement Be sure to remove the disposable Hard Bearing Alignment Guide. It is not intended for implantation. In the event that the Hard Bearing Alignment Guide is disengaged from the liner, the alignment guide should be reassembled to the liner before implantation. This is accomplished by taking the disposable alignment guide and placing it upside down on the back table. The liner can then be placed upside down on the alignment guide such that the peripheral rim is sitting on the alignment guide. Simply push the liner onto the guide until the insertion ring locks snugly on the liner. The assembly is ready for placement in the shell. 10 Specific to R3™ ceramic liners Use extreme care in handling and storage of ceramic implant components. Damage to components may induce internal stresses that are not obvious to the observer, and it may lead to premature failure of the component. Before use of ceramic implants, carefully examine each component for indications of damage that may have occurred during shipping or prior in-hospital handling. All surfaces should be smooth without pitting, scratches or other surface irregularities. Only Smith & Nephew ceramic femoral heads can Surgical tip: be used with the R3 ceramic acetabular liners. • Should a correction or revision of a R3 Do not mix the ceramic liner or ceramic head ceramic liner be necessary, a new R3 with any other manufacturer’s acetabular shell or ceramic insert must be used. stem, respectively. Use the appropriate size head • The ceramic liner can be removed by and liner only. A sizing mismatch may result in placing the liner removal tool in the premature implant failure. Once the liner or the removal slot and prying (or impacting if head are impacted, the ridges machined into the necessary) the liner loose. metal taper deform. If, for any reason, the ceramic femoral head is removed, the metal stem taper cannot be reused with a ceramic component. If the R3 ceramic liner is removed, a new R3 ceramic liner must be used. Head compatibility with liners XLPE Liners may be used with CoCr, OXINIUM™ and ceramic heads. Constrained Liners may be used with CoCr, and OXINIUM heads. Ceramic liners may only be used with ceramic heads.Use the appropriate size head for the liner as a sizing mismatch may result in premature implant failure. 11 Hard Bearing Liner insertion 1 2 3 4 12 Shell and liner offerings XLPE Ceramic Cups 22 28 32 36 40 44 32 36 40 42 44 46 48 50 52 54 56 58 60 62 64 66 68 70 72 74 76 78 80 Range of motion1,2†* (SPECTRON™ stem [size 3], +4 head offset) REFLECTION™ Acetabular System with XLPE liner 22mm 28mm 32mm 36mm 0º 133º 142º 145º 148º 20º 112º 122º 126º 128º R3™ Acetabular System with XLPE liner 22mm 28mm 32mm 36mm 40mm 44mm 0º 140º 150º 154º 157º 157º 157º 20º 132º 134º 136º 138º 138º 138º * Individual results in patients may vary. † Based on computer modelling. 13 Poly thickness chart Poly Poly Poly Thickness Poly Thickness Thickness Load- Thickness Load- Taper Bearing Taper Bearing Region Region Region Region Shell OD Poly OD mm mm Shell OD Poly OD mm mm 40 22 5.5 6.1 62 32 11.3 12.1 42 22 6.5 7.1 62 36 9.3 10.1 44 22 7.5 8.1 62 40 7.5 8.0 46 28 5.4 6.1 62 44 5.3 6.0 48 28 6.4 7.1 64 36 10.3 11.1 48 32 4.3 5.1 64 40 8.4 9.0 50 28 7.3 8.1 64 44 6.4 7.0 50 32 5.3 6.1 66-70 36 11.3 12.1 52 28 8.3 9.1 66-70 40 9.3 10.0 52 32 6.3 7.1 66-70 44 7.2 8.0 52 36 4.3 5.1 72-74 36 13.8 14.0 54 28 9.3 10.1 72-74 40 11.8 12.0 54 32 7.3 8.1 72-74 44 9.8 10.0 54 36 5.3 6.1 76-80 36 15.8 16.0 56 28 10.3 11.1 76-80 40 13.8 14.0 56 32 8.3 9.1 76-80 44 11.8 12.0 56 36 6.3 7.1 56 40 4.6 5.0 58 28 11.3 12.1 58 32 9.3 10.1 Taper region 58 36 7.3 8.1 58 40 5.3 6.0 60 28 12.3 13.1 60 32 10.3 11.1 60 36 8.3 9.1 60 40 6.5 7.0 Load-bearing 60 44 4.3 5.0 14 Catalog R3™ NO HOLE Acetabular Shells Standard size shells Small size shells Cat. no. ODmm Cat. no. ODmm 71331846 46 71331840 40 71331848 48 71331842 42 71331850 50 71331844 44 71331852 52 71331854 54 Large size shells 71331856 56 Cat. no. ODmm 71331858 58 71331866 66 71331860 60 71331868 68 71331862 62 71331864 64 R3 NO HOLE HA Acetabular Shells Standard size shells Small size shells Cat. no. ODmm Cat. no. ODmm 71332246 46 71332240 40 71332248 48 71332242 42 71332250 50 71332244 44 71332252 52 71332254 54 Large size shells 71332256 56 Cat. no. ODmm 71332258 58 71332266 66 71332260 60 71332268 68 71332262 62 71332264 64 R3 THREE HOLE Acetabular Shells Standard size shells Small size shells Cat. no. ODmm Cat. no. ODmm 71335546 46 71335540 40 71335548 48 71335542 42 71335550 50 71335544 44 71335552 52 71335554 54 Large size shells 71335556 56 Cat. no. ODmm 71335558 58 71335566 66 71335560 60 71335568 68 71335562 62 71335564 64 15 R3™ THREE HOLE HA Acetabular Shells Standard size shells Small size shells Cat. no. ODmm Cat. no. ODmm 71331946 46 71331940 40 71331948 48 71331942 42 71331950 50 71331944 44 71331952 52 71331954 54 Large size shells 71331956 56 Cat. no. ODmm 71331958 58 71331966 66 71331960 60 71331968 68 71331962 62 71331964 64 R3 MULTI HOLE Acetabular Shells Standard size shells Large size shells Cat. no. ODmm Cat. no. ODmm 71338663 48 71338673 66 71338664 50 71338674 68 71338665 52 71338675 70 71338666 54 71338667 56 Jumbo size shells 71338668 58 Cat. no. ODmm 71338669 60 71338676 72 71338671 62 71338677 74 71338672 64 71338678 76 71330009 78 71330010 80 R3 HA MULTI HOLE Acetabular Shells Standard size shells Large size shells Cat. no. ODmm Cat. no. ODmm 71338733 48 71338742 66 71338734 50 71338743 68 71338735 52 71338744 70 71338736 54 71338737 56 Jumbo size shells 71338738 58 Cat. no. ODmm 71338739 60 71338745 72 71338740 62 71338747 74 71338741 64 71338749 76 71331138 78 71331139 80 16 R3™ XLPE Acetabular Liners 0° XLPE liner 20° XLPE liner 0° +4 XLPE liner 20°+4 XLPE liner ID OD Cat. no. Cat. no. Cat. no. Cat. no. 22 40 71334840 71334940 71335840 71337140 22 42 71334842 71334942 71335842 71337142 22 44 71334844 71334944 71335844 71337144 28 46 71337546 71334946 71335946 71337746 28 48 71337548 71334948 71335948 71337748 28 50 71337550 71334950 71335950 71337750 28 52 71337552 71334952 71335952 71337752 28 54 71337554 71334954 71335954 71337754 28 56 71337556 71334956 71335956 71337756 28 58 71337558 71334958 71335958 71337758 28 60 71337560 71334960 71335960 71337760 32 48 71339548 71337648 71336648 71337948 32 50 71339550 71337650 71336650 71337950 32 52 71339552 71337652 71336652 71337952 32 54 71339554 71337654 71336654 71337954 32 56 71339556 71337656 71336656 71337956 32 58 71339558 71337658 71336658 71337958 32 60 71339560 71337660 71336660 71337960 32 62 71339562 71337662 71336662 71337962 36 52 71332752 71335752 71336952 71338552 36 54 71332754 71335754 71336954 71338554 36 56 71332756 71335756 71336956 71338556 36 58 71332758 71335758 71336958 71338558 36 60 71332760 71335760 71336960 71338560 36 62 71332762 71335762 71336962 71338562 36 64 71332764 71335764 71336964 71338564 36 66-70 71330766 71331266 71331566 71332666 36 72-74 71338686 71338694 71338703 71338712 36 76-80 71331103 71331112 71331114 71338946 17 R3™ XLPE Acetabular Liners (continued) 0° XLPE liner 20° XLPE liner 0° +4 XLPE liner 20°+4 XLPE liner ID OD Cat. no. Cat. no. Cat. no. Cat. no. 40 56 71338679 71338687 71338695 71338704 40 58 71338680 71338688 71338696 71338705 40 60 71338681 71338689 71338697 71338706 40 62 71338682 71338690 71338698 71338707 40 64 71338683 71338691 71338699 71338708 40 66-70 71338684 71338692 71338701 71338709 40 72-74 71338685 71338693 71338702 71338711 40 76-80 71331094 71331104 71331113 71331116 44 60 71331096 71331106 71330011 71331118 44 62 71331097 71331107 71330012 71331119 44 64 71331098 71331108 71330013 71331121 44 66-70 71331099 71331109 71330014 71331122 44 72-74 71331101 71331110 71330016 71331123 44 76-80 71331102 71331111 71330017 71331124 18  R3™ INTL Delta Ceramic Liners* ID OD Cat. no. 32 48 71331748 32 50 71331750 36 52 71331752 36 54 71331754 36 56 71331756 36 58 71331758 36 60 71331760 36 62 71331762 36 64 71331764 36 66/68 71331766 * For Use with Smith & Nephew BIOLOX® Delta and BIOLOX Forte Ceramic Heads only. 19 R3™ Trial Shells Standard size trial shells Small size trial shells Cat. no. ODmm Cat. no. ODmm 71360745 45 71360739 39 71360746 46 71360740 40 71360747 47 71360741 41 71360748 48 71360742 42 71360749 49 71360743 43 71360750 50 71360744 44 71360751 51 71360752 52 Large size trial shells 71360753 53 Cat. no. ODmm 71360754 54 71360765 65 71360755 55 71360766 66 71360756 56 71360767 67 71360757 57 71360768 68 71360758 58 71366524 69 71360759 59 71366525 70 71360760 60 71360761 61 Jumbo size trial shells 71360762 62 Cat. no. ODmm 71360763 63 71366526 71 71360764 64 71366527 72 71366528 73 71366529 74 71366530 75 71366531 76 71362019 77 71362020 78 71362021 79 71362022 80 20 Catalog R3™ Poly Trial Liners 20° XLPE trial 0° XLPE trial liner liner 0° +4 XLPE trial 20°+4 XLPE trial ID OD Cat. no. Cat. no. liner Cat. no. liner Cat. no. 22 40 71360540 71365340 71366140 71368640 22 42 71360542 71365342 71366142 71368642 22 44 71360544 71365344 71366144 71368644 28 46 71360546 71366446 71368346 71368746 28 48 71360548 71366448 71368348 71368748 28 50 71360550 71366450 71368350 71368750 28 52 71360552 71366452 71368352 71368752 28 54 71360554 71366454 71368354 71368754 28 56 71360556 71366456 71368356 71368756 28 58 71360558 71366458 71368358 71368758 28 60 71360560 71366460 71368360 71368760 32 48 71365148 71366548 71368448 71368848 32 50 71365150 71366550 71368450 71368850 32 52 71365152 71366552 71368452 71368852 32 54 71365154 71366554 71368454 71368854 32 56 71365156 71366556 71368456 71368856 32 58 71365158 71366558 71368458 71368858 32 60 71365160 71366560 71368460 71368860 32 62 71365162 71366562 71368462 71368862 36 52 71365252 71367952 71368552 71369152 36 54 71365254 71367954 71368554 71369154 36 56 71365256 71367956 71368556 71369156 36 58 71365258 71367958 71368558 71369158 36 60 71365260 71367960 71368560 71369160 36 62 71365262 71367962 71368562 71369162 36 64 71365264 71367964 71368564 71369164 36 66-70 71365266 71367966 71368566 71369166 36 72-74 71366571 71366574 71366577 71366580 36 76-80 71362312 71362314 71362316 71362318 21 R3™ Poly Trial Liners 20° XLPE trial 0° XLPE trial liner liner 0° +4 XLPE trial 20°+4 XLPE trial ID OD Cat. no. Cat. no. liner Cat. no. liner Cat. no. 40 56 71363420 71363422 71362030 71362035 40 58 71362023 71362026 71362031 71362036 40 60 71362024 71362027 71362032 71362037 40 62 71363421 71362028 71362033 71362038 40 64 71362025 71362029 71362034 71362039 40 66-70 71366569 71366572 71366575 71366578 40 72-74 71366570 71366573 71366576 71366579 40 76-80 71362311 71362313 71362315 71362317 44 60 71366081 71366094 71366087 71366101 44 62 71366082 71366095 71366088 71366102 44 64 71366083 71366096 71366089 71366103 44 66-70 71366084 71366097 71366091 71366104 44 72-74 71366085 71366098 71366092 71366105 44 76-80 71366086 71366099 71366093 71366106 22 R3™ Ceramic Snap in Trial Liners ID OD Cat. no. 32 48 71369748 32 50 71369758 36 52 71369752 36 54 71369754 36 56 71369756 36 58 71369758 36 60 71369760 36 62 71369762 36 64 71369764 36 66/68 71369766 R3 Liner Impactor Heads Cat. no. Size mm 71366428* 28 71366432* 32 71366436* 36 71366438* 38-42 71366444* 44-48 71366451* 50-54 *Exclusively for liner impaction Note: When using a 22mm Liner, you will need to order a Reflection 22mm Impactor Head (71362222) separately. R3 MIS Instruments Cat. no. Description 71368569 Offset Shell Impactor 71366052 Offset X-Bar 71363077 Offset Impactor Tip 71364073 Offset Reamer Handle 23 Catalog R3™ Straight Shell Impactor Cat. no. 71364450 R3 Impactor Replacement Tip Cat. no. 71368570 R3 Depth Gauge Cat. no. 71364451 X-Bar Cat. no. MT-2201 Screw Forceps Cat. no. 71362298 Ball Joint Screwdriver Cat. no. 71362295 R3 Variable Angle Drill Guide Cat. no. 71364477 Reamer Handle Cat. no. 71362279 Flexible Screw Drills Cat. no. Length mm 71362915 15 71362925 25 71362935 35 71362950 50 Captured Flexible Screwdriver Shaft Cat. no. 71362291 Captured U-Joint Screwdriver Shaft Cat. no. 71362292 R3 Surgical Templates sizes 40-68 (not shown) Cat. no. 71380666 R3 Surgical Templates sizes 70-80 (not shown) Cat. no. 71381508 24 R3™ Trial Liner Removal Tool Cat. no. 71364455 R3 Liner Removal Tool Cat. no. 71366021 Hole Cover Impactor Cat. no. 73-2117 Trial Shell Handle Cat. no. 71362297 Flexible Screwdriver Cat. no. 71362290 Ratchet Handle Cat. no. 71362294 Small Slap Hammer Cat. no. 71367541 REFLECTION™ Mallet Cat. no. 71362106 Hole Cover Inserter Cat. no. 73-2133 Straight Screwdriver Shaft Cat. no. 71362293 Power Adaptors (not shown) Cat. no. 71362781 Synthes 71362782 Asculap 71362783 Hudson 25 Catalog Reamer Domes Standard size Small size Cat. no. Size mm Cat. no. Size mm 71362742 42 71362738 38 71362743 43 71362739 39 71362744 44 71362740 40 71362745 45 71362741 41 71362746 46 71362747 47 Large size 71362748 48 Cat. no. Size mm 71362749 49 71362765 65 71362750 50 71362766 66 71362751 51 71362767 67 71362752 52 71362768 68 71362753 53 71362769 69 71362754 54 71362770 70 71362755 55 71362771 71 71362756 56 71362772 72 71362757 57 71362773 73 71362758 58 71362774 74 71362759 59 71362775 75 71362760 60 71362776 76 71362761 61 71362777 77 71362762 62 71362778 78 71362763 63 71362779 79 71362764 64 71362780 80 26 R3™/REFLECTION™ Threaded Hole Cover Cat. no. 71336500 Spherical Head Screws Cat. no. Length mm 71332515 15 71332520 20 71332525 25 71332530 30 71332535 35 71332540 40 71332545 45 71332550 50 71332555 55 71332560 60 71332565 65 71332570 70 R3 Screw Hole Cover Cat. no. 71369894 Small Outer Case Cat. no. 71129401 (not shown) Lid for Outer Case Cat. no. 71129402 (not shown) R3 Trial Shell Tray Cat. no. 71362213 (not shown) R3 Main Instrument Tray Cat. no. 71362211 (not shown) R3 MIS Instrument Tray Cat. no. 71362219 (not shown) R3 Primary Reamer Dome Tray Cat. no. 71362212 (not shown) R3 CDH Trial Tray Cat. no. 71361077 (not shown) 27 Catalog R3™ Jumbo Trial Shell & Reamer Set Cat. no. 71362230 R3 XL Revision Reamer Set Cat. no. 71362160 R3 XL Revision Trial Shell Set Cat. no. 71362170 R3 Jumbo Trial Liner Set 66-70mm Cat. no. 71362090 R3 XL 0 Deg. Trial Liner Set 71-80mm Cat. no. 71362180 R3 XL 20 Deg. Trial Liner Set 71-80mm Cat. no. 71362190 R3 0 Deg. Multi ID Trial Liner Set 46-64mm Cat. no. 71360675 R3 20 Deg. Multi ID Trial Liner Set 46-64mm Cat. no. 71360681 R3 0 Deg. +4 Multi ID Trial Liner Set 46-64mm Cat. no. 71360676 R3 20 Deg. +4 Multi ID Trial Liner Set 46-64mm Cat. no. 71360683 R3 Ceramic Trial Liner Set 48-64mm Cat. no. 71360685 R3 0° 40mm Trial Liner Tray Cat. no. 71360782 R3 20° 40mm Trial Liner Tray Cat. no. 71360783 R3 0° +4 40mm Trial Liner Tray Cat. no. 71360784 R3 20° +4 40mm Trial Liner Tray Cat. no. 71360786 R3 0° and 20° 44mm Permanent Trial Liner Tray 60-70mm Cat. no. 71366981 R3 0° and 20° +4 44mm Permanent Trial Liner Tray 60-70mm Cat. no. 71366982 R3 0° and 20° +4 44mm Permanent Trial Liner Tray 72-80mm Cat. no. 71366983 28 Notes Notes References 1. Barrack RL, Thornberry RL, Ries MD, Lavernia C, Tozakoglou E. The Effect of Component Design on Range of Motion to Impingement in Total Hip Arthroplasty. AAOS Instructional Course Lectures. 2001;50:275 - 280. 2. Thornberry RL, Lavernia CJ, Barrack RL, Tozakoglou E. The Effects of Neck Geometry in Acetabular Design on Motion to Impingement. Paper presented at: AAHKS Eighth Annual Meeting; 1998. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Smith & Nephew representative or distributor if you have questions about the availability of Smith & Nephew products in your area. Smith & Nephew, Inc. www.smith-nephew.com 7135 Goodlett Farms Parkway Cordova, TN 38016 USA Telephone: 1-901-396-2121 Information: 1-800-821-5700 Orders and Inquiries: 1-800-238-7538 ©2022 Smith & Nephew ™ Trademark of Smith & Nephew. All rights reserved. All Trademarks acknowledged. 01069 V4 71381560 REVC 12/22  SP-CL HX Anatomically Adapted Cementless Hip System Explanation of Pictograms Manufacturer Article number Product meets the applicable requirements, which are regulated in Material (number) the EU harmonization legislation for the affixing of the CE marking. Contents SP-CL HX Anatomically Adapted Cementless Hip System Surgical Technique 02 Preoperative Planning 05 Surgical Approaches 06 Surgical Technique Implants 10 SP-CL Hip Stems, standard, CCD 126° 11 SP-CL Hip Stems, standard, CCD 135° 12 SP-CL Hip Stems, lateralized, CCD 126° Instruments 13 Instrument Set for SP-CL Hip System 17 Handle for Compressor Stems 18 Additional Instruments Accessories 18 Instructions for Cleaning and Maintenance, X-ray Templates 19 Literature 20 Indications / Contraindications Important Information 01  Surgical Technique Preoperative Planning Preoperative planning is conducive towards optimal When evaluating the X-rays, it is important to factor in surgical outcomes by ensuring the most appropriate any magnification incurred (Abb. 1). Two factors are implants are selected for the patient. The key ob- decisive: jectives involved are the correct positioning of the central rotational point of the hip, correct leg length 1) Focal distance and finally preservation or restoration of sufficient Focal spot X-ray tube x Film cassette soft tissue tension by avoiding medialisation of the A focal distance of 100 cm gives magnification of femur. about 10%. Achieving anatomically appropriate CCD or neck 2) Object film distance angle and head-neck length are of paramount im- Femoral axis x Film cassette portance. The SP-CL system offers the CCD angles 126° and 135° as well as a 126° lateralized version. This combined with femoral heads with up to four Focal spot X-ray tube head-neck lengths allows the surgeon great flexibility. Planning should ideally be based on two X-rays: Focal distance an AP film of the pelvis and a mediolateral X-ray of the hip in question. When performing the pelvic 2 X-ray it is important to ensure that: Object film distance 1 1. Both femurs are shown in their entirety. Film level 2. The femurs are straight and parallel and, if (Cassette) possible, internally rotated approximately 5° in that position. Fig. 1 3. Key landmarks needed for planning are visible: the inferior margins of the obturator foramen and of the acetabular teardrop. 02 Surgical Technique Practical steps First, geometrical measurements are taken on the This provides an overview and landmarks for orien- basis of the pelvic radiograph. This can be done tation during surgery, e.g. transfer of dimensional on the X-ray directly (Fig. 2), but it is better to trace reference to the bone. It must always be remem- the skeletal contours onto tracing paper (Fig. 3). bered that the measurements on the radiograph include a magnification effect that must be allowed A horizontal reference line is drawn along the inferior for if the measurements are transferred to bone. margins of the obturator foramen, followed by a If the magnification is 10%, measurements taken vertical reference line along the sacral crest, ideally from the radiograph must be divided by 1.1. So, for passing through the center of the pubic symphysis. example, 60 mm apparent ÷ 1.1 = 54.5 mm actual measurement. The same applies for other magnifica- From these two lines, the center of rotation, tions: e.g. at 15% magnification a 60 mm apparent difference in leg length, left/right femoral distance, measurement gives 60 mm ÷ 1.15 = 52.2 mm actual distance between the left/right muscle T lever arms, measurement. etc. are defined and marked on the tracing paper. Fig. 2 Fig. 3 Once the dimensions have been entered, the tem- In addition to pelvic radiograph, the mediolateral plates are used to select the best implant com- radiograph is used to determine the stem shape ponents for the particular case. The template is and size of the femoral prosthesis as seen from the positioned on the radiograph such that the center lateral view. of rotation coincides with the anatomical center of rotation as determined in the drawing. The implant components selected should correct any ana­tomical insufficiencies derived from the measurements. 03  Surgical Technique The planned result becomes clearer when the Materials required: transparent sheet with the outlined skeletal contours, 1. Tracing paper measurements, and sketched-in position of the 2. Transparent ruler, 1:1 acetabular cup is placed on top of the radiograph and 3. Transparent protractor adjusted so that the femur in the radiograph is in the 4. Transparent radius/hole template desired outcome position in relation to the drawing Ø 24 to 58 mm, in 2 mm increments of the pelvis. This position is then traced onto the tracing paper, preferably in a different color (Fig. 4). The differences on the tracing paper, e.g. actual and INFORMATION: planned positions of the femur, provide the visual Preoperative planning may be time-consuming over­view required for surgical planning and precise but it provides intraoperative guidance and can selection of the implant components using the X-ray enhance the final result. templates or, if necessary, for custom-design implants (Fig. 5). Fig. 4 Fig. 5 04 Surgical Technique Surgical Approaches The choice of the approach depends on the surgeon‘s experience and his/her decision based on the individual situation. The following approaches are usual: - antero-lateral - Watson Jones (Fig. A) - direct lateral - Hardinge (Fig. B) - postero-lateral - Moore (Fig. C) Fig. A: Watson Jones Fig. B: Hardinge Fig. C: Moore 05  Surgical Technique Surgical Technique Implantation of the acetabular cup Avoid damaging the acetabular metal casing when implanting the cup prior to the implantation of the stem (Fig. 1). Resection of the femoral neck The hip is dislocated in the usual way. The standard osteotomy plane is normally at 45° to the axis of the Fig. 1 femoral stem. For purposes of orientation the resection guide can be placed on the lesser trochanter parallel to the longitudinal axis of the femur (Fig. 2). Resection can then be carried out along the slit corresponding to the level selected in preoperative planning. The guide indicates both the level and the angle of resection. Care should be taken to ensure that resection is also carried out at 90° to the axis of the femoral Fig. 2 neck in the a-p plane. A second vertical resection may be necessary in certain cases (Fig. 3). A compressor can also be used to check that the orientation of the resection plane is correct. The acetabular cup is almost always prepared before the stem. Fig. 3 Preparation of the femur The medullary cavity is opened with a gouge. This should be done as far laterally as possible to avoid varus positioning of the stem (Fig. 4 + 5). This also makes it easier to insert the compressor and drasti- cally reduces the risk of fracturing the femoral shaft when driving in the prosthesis. Fig. 4 Fig. 5 06 Surgical Technique The opening compressor can be used to prepare the cancellous bone in the lateral area of the great trochanter to prevent varus positioning of the com- pressor and the implant. After the medullary cavity has been opened, it is pre- pared with the smallest compressor size. Attention should also be paid to the axial orientation during this process. To fit the compressor, the lever on the handle is opened Fig. 6 and the compressor is inserted with its medial side facing the lever. The lever is then closed again. The anatomical form of the compressors means that the anteversion usually adjusts itself automatically when they are driven in. The femoral canal is prepared with compressor of increasing size until maximum stability is achieved. The process is complete as soon as the compressor is positioned in the femo- ral canal so that it is rotationally stable, central and aligned with the axis. INFORMATION: The compressor size is not necessarily the same as in preoperative planning, but can vary up to Fig. 7 two sizes. SP-CL stems are fixed in a bed of compacted can- cellous bone. The compressors used ensure that the bone substance is compacted without removing it from the bone. When driving the compressors in and out, unintentional turning movements of the handle/ compressor unit should be avoided to prevent damage to the implant bed. Fig. 8 INFORMATION: The SP-CL compressors have a marking line a few millimeters below the handle attachment point. The height of this line on the compressor is exactly at the level of the transition between the modified surface and the blasted neck sec- tion of the SP-CL stem. The final prosthesis stem is driven in with reference to this line up to the corresponding position of the last compressor. The position required for this component can Fig. 9 thus be reproduced exactly. 07  Surgical Technique Trial reduction The acetabular component is usually implanted before the stem so that trial reduction is possible. This is carried out with the final size of compressor in situ. The handle is removed and the trial neck segment selected in preoperative planning (CCD angle, type) is placed on the compressor. The different trial heads are then used to check for optimal offset and correct leg length and to test whether stability is adequate. Fig. 10 The range of movement is also checked to avoid impingement of bone and implant and rule out any instability. The combination of the prosthetic head with the trial neck segments is not permissable. When all checks have been made, the trial head and trial neck segments are removed by hand. The handle is then used to remove the compressor, which is still in situ, from the femoral canal. Fig. 11 Implanting the final stem The stem to be used (size, CCD angle, type) has been determined by performing trial reduction. The appropriate implant is now removed from the sterile packaging and inserted manually as far into the medullary canal as possible. This helps to protect the prepared implant bed. The tip of the impactor is placed in the lateral depression on the upper surface of the prosthesis. The design of the impactor ensures that any lateral forces occurring during implantation do not reach Fig. 12 the stem (Fig. 12). 08 Surgical Technique Using steady hammer blows the stem is now care- fully driven in until it reaches its final position. This is indicated when the transition line on the prosthesis is at the same height as that on the compressor last used (Figure 13). Trial reduction can then be repeated. The selected trial head is placed on the implant and trial reduction is carried out. The trial head is then removed again. Abb. 13 Fig. 13 Attaching the final prosthesis head The taper of the stem is cleaned and dried thoroughly. This is particularly important with ceramic heads. The head is then attached by hand with axial pres- sure and a turning movement. The head is hit lightly with the driver (Fig. 14 + 15). Once the joint surfaces have been cleaned the joint is reduced with the final implant components. The wound is closed in layers. Abb. 14 Fig. 14 Removing the components The different components can be removed if required. The prosthesis head can be removed separately in an axial direction using a plunger/stem/rod which is placed at the base of the head. The femoral component can be driven out with the extraction instrument (130-252/00), which is con- nected to the compressor handle with the adapter. CAUTION: If a ceramic head has to be replaced with ano- ther ceramic head, only ceramic revision heads with a metal inner taper must be used. Fig. 15 09  Implants SP-CL Hip Stem, standard, CCD 126° Tilastan-S (Ti6Al4V), HX-coated Offset A A D L C B B Offset L A B C D RIGHT LEFT Stem size mm mm mm mm mm mm 177-200/26* 177-220/26* 1 34.7 115 14.4 5.4 6.4 22.5 177-201/26* 177-221/26* 2 36.1 120 15.0 5.6 6.7 23.4 177-202/26* 177-222/26* 3 37.4 125 15.5 5.8 6.9 24.3 177-203/26 177-223/26 4 38.8 130 16.1 6.0 7.2 25.2 177-204/26 177-224/26 5 40.2 135 16.7 6.2 7.4 26.1 177-205/26 177-225/26 6 41.6 140 17.3 6.5 7.7 27.0 177-206/26 177-226/26 7 43.0 145 17.8 6.7 7.9 27.9 177-207/26 177-227/26 8 44.4 150 18.4 6.9 8.2 28.8 177-208/26 177-228/26 9 45.8 155 19.0 7.1 8.4 29.7 177-209/26 177-229/26 10 47.2 160 19.6 7.3 8.7 30.6 177-210/26 177-230/26 11 48.6 165 20.1 7.5 8.9 31.5 177-211/26 177-231/26 12 49.6 165 20.7 7.8 9.2 32.2 177-212/26 177-232/26 13 50.5 165 21.3 8.0 9.5 33.2 177-213/26 177-233/26 14 51.5 165 21.8 8.2 9.7 34.0 177-214/26 177-234/26 15 52.5 165 22.4 8.5 10.0 34.8 177-215/26 177-235/26 16 53.5 165 23.0 8.7 10.3 35.6 177-241/26 177-251/26 18 53.5 165 24.2 9.1 10.8 37.2 177-243/26 177-253/26 20 53.5 165 25.4 9.6 11.3 38.8 177-245/26 177-255/26 22 53.5 165 26.5 10.0 11.9 40.4 * on request, not part of the standard set configuration 10 Implants SP-CL Hip Stem, standard, CCD 135° Tilastan-S (Ti6Al4V), HX-coated Offset A A D L C B B Offset L A B C D RIGHT LEFT Stem size mm mm mm mm mm mm 177-400/35* 177-420/35* 1 33.2 115 14.4 5.4 6.4 22.5 177-401/35* 177-421/35* 2 34.5 120 15.0 5.6 6.7 23.4 177-402/35* 177-422/35* 3 35.7 125 15.5 5.8 6.9 24.3 177-403/35 177-423/35 4 37.0 130 16.1 6.0 7.2 25.2 177-404/35 177-424/35 5 38.3 135 16.7 6.2 7.4 26.1 177-405/35 177-425/35 6 39.6 140 17.3 6.5 7.7 27.0 177-406/35 177-426/35 7 40.9 145 17.8 6.7 7.9 27.9 177-407/35 177-427/35 8 42.1 150 18.4 6.9 8.2 28.8 177-408/35 177-428/35 9 43.4 155 19.0 7.1 8.4 29.7 177-409/35 177-429/35 10 44.7 160 19.6 7.3 8.7 30.6 177-410/35 177-430/35 11 46.0 165 20.1 7.5 8.9 31.5 177-411/35 177-431/35 12 46.8 165 20.7 7.8 9.2 32.2 177-412/35 177-432/35 13 47.7 165 21.3 8.0 9.5 33.2 177-413/35 177-433/35 14 48.6 165 21.8 8.2 9.7 34.0 177-414/35 177-434/35 15 49.6 165 22.4 8.5 10.0 34.8 177-415/35 177-435/35 16 50.3 165 23.0 8.7 10.3 35.6 177-441/35 177-451/35 18 50.3 165 24.2 9.1 10.8 37.2 177-443/35 177-453/35 20 50.3 165 25.4 9.6 11.3 38.8 177-445/35 177-455/35 22 50.3 165 26.5 10.0 11.9 40.4 * on request, not part of the standard set configuration 11  Implants SP-CL Hip Stem, lateralized, CCD 126° Tilastan-S (Ti6Al4V), HX-coated Offset A A D L C B B Offset L A B C D RIGHT LEFT Stem size mm mm mm mm mm mm 177-603/26 177-623/26 4 45.3 130 16.1 6.0 7.2 25.2 177-604/26 177-624/26 5 46.7 135 16.7 6.2 7.4 26.1 177-605/26 177-625/26 6 48.1 140 17.3 6.5 7.7 27.0 177-606/26 177-626/26 7 49.5 145 17.8 6.7 7.9 27.9 177-607/26 177-627/26 8 50.8 150 18.4 6.9 8.2 28.8 177-608/26 177-628/26 9 52.2 155 19.0 7.1 8.4 29.7 177-609/26 177-629/26 10 53.6 160 19.6 7.3 8.7 30.6 177-610/26 177-630/26 11 55.0 165 20.1 7.5 8.9 31.5 177-611/26 177-631/26 12 56.0 165 20.7 7.8 9.2 32.2 177-612/26 177-632/26 13 57.0 165 21.3 8.0 9.5 33.2 177-613/26 177-633/26 14 58.0 165 21.8 8.2 9.7 34.0 177-614/26 177-634/26 15 59.0 165 22.4 8.5 10.0 34.8 177-615/26 177-635/26 16 60.0 165 23.0 8.7 10.3 35.6 177-641/26 177-651/26 18 60.0 165 24.2 9.1 10.8 37.2 177-643/26 177-653/26 20 60.0 165 25.4 9.6 11.3 38.8 177-645/26 177-655/26 22 60.0 165 26.5 10.0 11.9 40.4 12 Instruments Instrument set for LINK SP-CL Hip Stems Compressors, right Compressors, left Compressors, extra large sizes, right and left Instrument Set, complete 175-110/00 Instrument set Instruments, complete 175-120/00 Instrument set Compressors, right, complete 175-130/00 Instrument set Compressors, left, complete 175-140/00 Instrument set Compressors, right and left, complete, extra large sizes 13  Instruments 175-110/00 Instrument set, complete 1 2 3 4 5-8 9-12 13-16 17-20 21 22 23 Description Qty. 1 175-111/00 Tray, only 1 2 175-380 Gouge 1 3 175-360 Impactor for prosthesis heads with exchangeable plastic head, 280 mm 1 4 130-622 Impactor 1 5 175-928/11 Plastic trial head 28 S 1 6 175-928/12 Plastic trial head 28 M 1 7 175-928/13 Plastic trial head 28 L 1 8 175-928/14 Plastic trial head 28 XL 1 9 175-932/11 Plastic trial head 32 S 1 10 175-932/12 Plastic trial head 32 M 1 11 175-932/13 Plastic trial head 32 L 1 12 175-932/14 Plastic trial head 32 XL 1 13 175-936/11 Plastic trial head 36 S 1 14 175-936/12 Plastic trial head 36 M 1 15 175-936/13 Plastic trial head 36 L 1 16 175-936/14 Plastic trial head 36 XL 1 17 175-940/11* Plastic trial head 40 S 1 18 175-940/12* Plastic trial head 40 M 1 19 175-940/13* Plastic trial head 40 L 1 20 175-940/14* Plastic trial head 40 XL 1 21 130-394/01 Handle for compressors with quick coupling stems 1 22 175-390 Compressor to start, curved 1 23 175-310/05 Resection guide, 72 mm 1 * on request, not part of the standard set configuration 14 Instruments 175-120/00 Instrument set, Compressors, RIGHT, complete 175-130/00 Instrument set, Compressors, LEFT, complete (NOT ILLUSTRATED) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Version Size Version Size 1 175-121/00 Compressor tray, RIGHT, empty 175-131/00 Compressor tray, LEFT, empty 2 175-200/01* right 1 175-201/01* left 1 3 175-200/02* right 2 175-201/02* left 2 4 175-200/03* right 3 175-201/03* left 3 5 175-200/04 right 4 175-201/04 left 4 6 175-200/05 right 5 175-201/05 left 5 7 175-200/06 right 6 175-201/06 left 6 8 175-200/07 right 7 175-201/07 left 7 9 175-200/08 right 8 175-201/08 left 8 10 175-200/09 right 9 175-201/09 left 9 11 175-200/10 right 10 175-201/10 left 10 12 175-200/11 right 11 175-201/11 left 11 13 175-200/12 right 12 175-201/12 left 12 14 175-200/13 right 13 175-201/13 left 13 15 175-200/14 right 14 175-201/14 left 14 16 175-200/15 right 15 175-201/15 left 15 17 175-200/16 right 16 175-201/16 left 16 Single angled Handle Single angled Handle 18 130-394/02* 130-394/03* for compressors, right for compressors, left * on request, not part of the standard set configuration Neck segment for fitting to compressor with taper 12/14 mm Description Type CCD Version for compressor- & stem size 19 175-195/26 Neck segment std. 126° right 1 - 16 20 175-197/26 Neck segment lat. 126° right 4 - 16 21 175-195/35 Neck segment std. 135° right 1 - 16 175-196/26 Neck segment std. 126° left 1 - 16 175-198/26 Neck segment lat. 126° left 4 - 16 175-196/35 Neck segment std. 135° left 1 - 16 15  Instruments 175-140/00 Instrument set, Compressors, complete, extra large sizes, right and left 1 2 3 4 5 6 7 Version Size 1 175-141/00 Compressor tray, empty 2 175-201/18 left 18 3 175-201/20 left 20 4 175-201/22 left 22 5 175-200/22 right 22 6 175-200/20 right 20 7 175-200/18 right 18 16 Instruments 130-394/01 Universal Handle for rasp stems and compressors 130-394/02 Universal Handle for rasp stems and compressors, angled, right 130-394/03 Universal Handle for rasp stems and compressors, angled, left Coupling of the compressor Fig. 1 To couple compressor and handle, the catch is retracted fully (left arrow). Then, the compressor fitting is inserted into the mount on the front of the handle (right arrow, Fig. 1). Fig. 2 To secure the connection between compressor and handle, the catch is pushed forwards (arrow) (Fig. 2). Fig. 3 To disengage open the handle again (arrow) (Fig. 3). The handle for compressors can then be detached from the compressor. 17  Instruments / Accessories Additional Instruments (not included in instrument set) 179-122 Insertion Forceps, lockable 179-122/01 Exchangeable Taper Cap for Insertion Forceps 179-122 130-252/00 Instrument set for extraction (not illustrated) Instructions for Cleaning and Maintenance Specific instructions for instruments are available on request: E-mail [email protected] X-ray Templates for SP-CL Hip Prosthesis Stems, cementless Stem Ti6Al4V, HX Coating, taper 12/14 mm, sizes 1-16, set with 16 sheets CCD angle Actual size 175-801/02 126° 110% 175-801/04 135° 110% 175-801/03 126° lateralized 110% 18 Literature Additional Information Catalogs on request: E-mail [email protected] For more information please register for our LINK Media Library (linkorthopaedics.com) 19  Indications/Contraindications SP-CL cementless Hip Prosthesis System (all types) General Indications Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures Indications Primary and secondary osteoarthritis Rheumatoid arthritis Correction of functional deformities Avascular necrosis Femoral neck fractures Revision surgeries Contraindications Acute and chronic infections, local and systemic insofar as they compromise the successful implantation of a total hip prosthesis (preoperative microbiological analysis recommended) Allergies to (implant) materials Insufficient / inadequate bone mass- or quality, which prevents a stable anchorage of the prosthesis The stems are indicated for cementless use only. INFORMATION: These indications/contraindications refer to standard cases. The ultimate decision on whether or not an implant is suitable for a patient must be made by the surgeon based on his/her individual analysis and his/her experience. The SP-CL hip prosthesis stem can only be combined with prosthesis heads that do not exceed +10.5 mm additional neck length. 20 Important Information Please note the following regarding the use of our implants: 1. Choosing the right implant is very important. The size and shape of the human bone determines the size and shape of the implant and also limits the load capacity. Implants are not designed to withstand unlimited physical stress. Demands should not exceed normal functional loads. 2. Correct handling of the implant is very important. Under no circumstances should the shape of a finished implant be altered, as this shortens its life span. Our implants must not be combined with implants from other manufacturers. The instruments indicated in the Surgical Technique must be used to ensure safe implantation of the components. 3. Implants must not be reused. Implants are supplied sterile and are intended for single use only. Used implants must not be used again. 4. After-treatment is also very important. The patient must be informed of the limitations of the implant. The load capacity of an implant cannot compare with that of healthy bone! 5. Unless otherwise indicated, implants are supplied in sterile packaging. Note the following conditions for storage of packaged implants: • Avoid extreme or sudden changes in temperature. • Sterile implants in their original, intact protective packaging may be stored in permanent buildings up until the “Use by” date indicated on the packaging. • They must not be exposed to frost, dampness or direct sunlight, or mechanical damage. • Implants may be stored in their original packaging for up to 5 years after the date of manufacture. The “Use by” date is indicated on the product label. • Do not use an implant if the packaging is damaged. 6. Traceability is important. Please use the documentation stickers provided to ensure traceability. 7. Further information on the material composition is available on request from the manufacturer. Follow the instructions for use! Waldemar Link GmbH & Co. KG, Hamburg All content in this catalog, including text, pictures and data, is protected by law. Every instance of use, whether in part or in whole and which is not permitted by law, is subject to our prior consent. In particular, this applies to the reproduction, editing, translation, publishing, saving, processing, or passing on of content stored in databases or other electronic media and systems, in any manner or form. The information in the catalogs is solely intended to describe the products and does not constitute a guarantee. The Surgical Technique described has been written to the best of our knowledge and belief, but it does not relieve the surgeon of his/her responsibility to duly consider the particularities of each individual case. Products shown in this document may not be available in your country. The product availability is subject to the approval and/or registration regulations of the respective country. Please contact Waldemar Link GmbH & Co. KG if you have questions about the availability of LINK products in your country. Waldemar Link GmbH & Co. KG and/or other corporate affiliated entities own, use or have applied for the following trademarks in many jurisdictions: LINK, BiMobile, SP II, Modell Lubinus, E-Dur, EndoDur, T.O.P. II, BetaCup, CombiCup PF, CombiCup SC, CombiCup R, MobileLink, C.F.P., LCU, SP-CL, LCP, MIT-H, Endo-Model, Endo-Model SL, MP, MEGASYSTEM-C, GEMINI SL, SPAR-K, LCK, Link OptiStem, HX, TiCaP, X-LINKed, PorAg, LINK PorEx, BiPorEx, PorEx-Z, TrabecuLink, Tilastan, customLINK, RescueSleeve, Stactip, VACUCAST. Other trademarks and trade names may be used in this document to refer to either the entities claiming the marks and/or names or their products and are the property of their respective owners. 21 © LINK 6462_SP-CL_HX_OP_EN_2021-12_003 MAR-01475 3.0 N Waldemar Link GmbH & Co. KG Barkhausenweg 10 · 22339 Hamburg · Germany Phone +49 40 53995-0 · [email protected] www.linkorthopaedics.com  SP-CL ® Anatomically Adapted Cementless Hip System “The most important advancement in total hip arthroplasty in the last 50 years has been the adaption of femoral components to the anatomy of the femur.“* Being one of the inventors of the anatomical prostheses design, LINK has more than three decades of experience in the development of this type of hip stems. The new anatomical cementless hip prostheses system SP-CL® from LINK represents a consistent progres- sion of the cemented Lubinus SP II® hip system towards cementless fixation – the SP II® concept that has proven its success in the Swedish Hip registry**. During the development of the SP-CL® the anatomical design features were subjected to various biomechanical tests. The result is a harmonically aligned hip prosthesis system, that provides a stable and long term solution for a large variety of patients with hip problems. It supports surgeons in their aim to operate gentle and less invasive and high reproducibility of clinical results is expected. * W.T. Stillwell. The Art of the Total Arthroplasty. Grune & Stratton, Inc. 1987; pp. 296 ** Annual Report 2012; Swedish Hip Arthroplasty Register; www.shpr.se Made in Germany Features of the SP-CL® Hip System: • Complementary to the cemented SP® family, backed by decades of successful use • Cementless metaphyseal fixation • Bioharmonic left and right stem types, each available in 13 standard sizes • Two CCD angles - 126° and 135° • Size and offset increase following stem growths from one size to the next Neutralising of torsional forces* acting on the proximal femur Photoelastic study of stresses Stress-load analysis proves that the true adaption to the femur of the LINK anatomi- cally shaped hip stems result in the most natural stress distribution, eliminating the harmful pinpoint stress concentration at the bone / implant interface. Straight stems produce S-shaped stems result stress risers in an in even stress distribution anatomically S-shaped medullar canal  Anatomic design and integrated antetorsion 5° The stems in the SP-CL® system have a 12/14 taper and can be combined with every modular ceramic or metal prosthesis head made by LINK. The stem has an anatomic design with an S-shaped curvature in M/L view. An antetorsion of 5° is integrated in the stem. Ribbed profile for excellent primary stability Designed with deep grooves and from LINK® Tilastan-S® alloy the SP-CL® results in a stem with constructive and material elasticity to act against stress shielding. The pronounced ribs provide primary stability.  Trochanter protecting Protects the greater trochanter due to flattened proximal lateral profile. LINK® HX® (CaP) coating The surface promotes osteoconduction and allows stable osseointegration for secondary stability. HX®-Coating (calcium phosphate) The HX®-Coating is an osteoconductive coating approxi- vertical, cristalline coating structure mately 15 µm thick. The proprietary electrochemical coating IIIIIIIII I approx. process results in extraordinary mechanical strength of the I I 15 µm coating, that endures the stress of implantation. The porous I I I I I cell structure of approx. 160 µm cell diameter of the substrate‘s Substrate surface is retained open, due to the thin overcoat and provides an optimal structure for osteoconduction. Polished distal stem For easy and safe insertion the polished surface allows distal gliding to counteract thigh pain.  Anatomical shape of the compressors Anatomically shaped stems require anatomically shaped instruments. The compressors of the SP-CL® system strictly follow the anatomical stem design and prepare a bony bed for the SP-CL® stem following the natural shape of the intramedullar canal of the proximal femur. The terraced profile of the compressors The SP-CL® stems are anchored in a bed of compacted cancellous bone. The teeth of the SP-CL® compressors ensure that the cancellous substance is firmly compacted.  High fixation zones Toothless bilateral isles for maximum grip of the proximal ribs. Press-fit The compressors and implants are matched to provide the optimal press-fit. Rounded distal tip of compressor for safe guidance and to avoid via falsa. © LINK 644_SP CL_Flyer_en_2017-08_004 Waldemar Link GmbH & Co. KG Barkhausenweg 10 · 22339 Hamburg, Germany P.O. Box 63 05 52 · 22315 Hamburg, Germany Tel.: +49 40 53995-0 · Fax: +49 40 5386929 E-mail: [email protected] · www.linkorthopaedics.com 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`( A  ,>+ "Q L-7, *>X= =#>?+,?+ +, a,7?S  ( $ AAb'  *Q7. "& 3200013/3K I7?+,+?  ` C  (NAPZ   M"++"7 Q I7?+,+?!"7," < =>??,  YBC ) O Cb  (NAPZ    DC  0&00 M"++"7 Q .."?7, 7# .?7.- (-1L- .A11ABM/ 5 EN<O8PQN86?8 R;6@; 5 -1.D/ JS1IAC3-BAS1 V!>7# 7,7,L7!9?+7++ 7,7, S7! *J2/EEK4431 //&0K&303E /4c/Kc32 :H H9 U7! I"7d 3 /E0/0 I>>77 +,  !""# /00043E3 3/3 JEJ 11.06.2025 VAIDLUSTUS Riigihange: „Traumatoloogia metallosteosünteesi vahendid ja liigeste endoproteesid“ viitenumber: 295377 Vaidlustaja: OneMed OÜ registrikood: 10891247 aadress: Veerenni 38, 10138 Tallinn Esindaja: Erki Fels, vandeadvokaat Gregor Saluveer, vandeadvokaadi abi Advokaadibüroo TGS Baltic e-post: [email protected] Hankija: sihtasutus Tartu Ülikooli Kliinikum registrikood: 90001478 aadress: L. Puusepa 1a, Tartu 50406 e-post: [email protected] TAOTLUSED 1. Peatada riigihanke „Traumatoloogia metallosteosünteesi vahendid ja liigeste endoproteesid“ (vr 295377) menetlus kõikides riigihanke osades. 2. Kohustada sihtasutust Tartu Ülikooli Kliinikum viima õigusaktidega kooskõlla järgmised riigihanke alusdokumentide tingimused: 2.1. riigihanke osa 4 alusdokumendi „Lisa 4 osa 4 - Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega“ punkt 3; 2.2. riigihanke osa 4 alusdokumendi „Lisa 4 osa 4 - Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega“ punkt 4.1; 2.3. riigihanke osa 4 alusdokumendi „Lisa 4 osa 4 - Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega“ punkt 5.1; 2.4. riigihanke osa 4 alusdokumendi „Lisa 4 osa 4 - Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega“ punkt 6.1; 2.5 riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 6.1; 2.6. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 8.1; 2.7. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 8.2; 2.8. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 9.2; 2.9. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 9.3; 2.10. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ punkt 9.6; Advokaadibüroo TGS Baltic AS Ahtri 6a, 10151 Tallinn Kaluri 2, 51004 Tartu [email protected] Telefon +372 626 4300 Telefon +372 730 1610 2.11. riigihanke osa 10 alusdokumendi „Lisa 10 osa 10 - Mittetsemeneteeritav puusaprotees (põhiproteesina)“ punkt 1.5; 2.12. riigihanke osa 10 alusdokumendi „Lisa 10 osa 10 - Mittetsemeneteeritav puusaprotees (põhiproteesina)“ punkt 1.6; 2.13. riigihanke osa 10 alusdokumendi „Lisa 10 osa 10 - Mittetsemeneteeritav puusaprotees (põhiproteesina)“ punkt 2.5; 2.14. riigihanke osa 10 alusdokumendi „Lisa 10 osa 10 - Mittetsemeneteeritav puusaprotees (põhiproteesina)“ punkt 2.8; 2.15. riigihanke osa 10 alusdokumendi „Lisa 10 osa 10 - Mittetsemeneteeritav puusaprotees (põhiproteesina)“ punkt 3.1; 2.16. riigihanke osa 11 alusdokumendi „Lisa 11 osa 11 - Mittetsemeneteeritav puusaprotees (alternatiiv)“ punkt 1.1; 2.17. riigihanke osa 11 alusdokumendi „Lisa 11 osa 11 - Mittetsemeneteeritav puusaprotees (alternatiiv)“ punkt 1.2; 2.18. riigihanke osa 11 alusdokumendi „Lisa 11 osa 11 - Mittetsemeneteeritav puusaprotees (alternatiiv)“ punkt 1.6; 2.19. riigihanke osa 11 alusdokumendi „Lisa 11 osa 11 - Mittetsemeneteeritav puusaprotees (alternatiiv)“ punkt 1.7; 2.20. riigihanke osa 11 alusdokumendi „Lisa 11 osa 11 - Mittetsemeneteeritav puusaprotees (alternatiiv)“ punkt 2.4; 2.21. riigihanke osa 1 alusdokumendis „Lisa 1 osa 1 - tsemeneteeritav standardne puusaprotees (põhi)“ sätestatud nõuded, sealhulgas peatükk „Muud täiendavad komponendid“; 2.22. riigihanke osa 2 alusdokumendis „Lisa 2 osa 2 - tsemeneteeritav standardne puusaprotees (alternatiiv)“ sätestatud nõuded, sealhulgas peatükk „Muud täiendavad komponendid“; 2.23. riigihanke osa 3 alusdokumendis „Lisa 3 osa 3 - puusaliigese eriprotees“ sätestatud nõuded, sealhulgas peatükid „Muud täiendavad komponendid“ ja „Lisavahendid“; 2.24. riigihanke osa 5 alusdokumendis „Lisa 5 osa 5 - Tsemeneteeritav põlveprotees tagumise ristatisideme stabiliseerimisega“ sätestatud nõuded, sealhulgas peatükid „Lisavõimalused“ ja „Teised lisavõimalused“; 2.25. riigihanke osa 7 alusdokumendis „Lisa 7 osa 7 - Põlveliigese eriprotees“ sätestatud nõuded, sealhulgas punkt 8; 2.26. riigihanke osa 13 alusdokumendis „Lisa 13 osa 13 - Megaprotees“ sätestatud nõuded; 2.27. riigihanke alusdokumendi „Lisa_24_pakkumuse_maksumus“ punkt 2.3; 2.28. riigihanke osa 4 alusdokumendi „Lisa 4 osa 4 - Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega“ peatükid „Muud täiendavad komponendid“, „Lisavahendid“ ja „Teised lisavõimalused“; 2.29. riigihanke osa 6 alusdokumendi „Lisa 6 osa 6 - Erikonstruktsiooniga tsemeneteeritav põlveprotees“ peatükid „Lisavõimalused“, „Teised lisavõimalused“ ja „Muud täiendavad komponendid ja võimalused“; 2.30. riigihanke osa 7 alusdokumendi „Lisa 7 osa 7 - Põlveliigese eriprotees“ peatükid „Lisavõimalused“, „Teised lisavõimalused“ ja „Muud täiendavad komponendid ja võimalused“; 2.31. riigihanke osa 8 alusdokumendi „Lisa 8 osa 8 - Õlaliigese protees“ peatükk „Muud täiendavad komponendid ja võimalused“; 2/13  2.32. riigihanke osa 9 alusdokumendi „Lisa 9 osa 9 - Küünarliigese protees“ peatükk „Muud täiendavad komponendid ja võimalused“; 2.33. riigihanke osade 1—14 tehniliste kirjelduste tingimused, mis algavad sõnadega „Endoproteesi komplekti baashinna arvutamiseks /…/“; 2.34 riigihanke osade 1—23 tehniliste kirjelduste tingimused, mis algavad sõnadega „Pakkuja peab hankijale tagama spetsiifiliste instrumentide komplektid /…/“; 2.35. riigihanke osade 1—23 tehniliste kirjelduste tingimused, mis algavad sõnadega „Garanteeritud instrumentide komplektide arv arvestatakse /…/“ ja „Lisaks garanteeritud instrumentide komplektidele /…/“; 2.36. riigihanke alusdokumendi „Juhised pakkujale“ punktid 6.18—6.18.2 ja 7.2. 3. Jätta OneMed OÜ menetluskulud sihtasutuse Tartu Ülikooli Kliinikum kanda. 1. ASJAOLUD 1.1. 19.05.2025 avaldas sihtasutus Tartu Ülikooli Kliinikum (hankija) avatud hankemenetlusena läbiviidava riigihanke „Traumatoloogia metallosteosünteesi vahendid ja liigeste endoproteesid“ (vr 295377) (riigihange) hanketeate ja tegi kättesaadavaks riigihanke alusdokumendid (RHAD). Tehnilise kirjelduse (TK) järgi on hankelepingu esemeks traumatoloogia metallosteosünteesi vahendite ja liigeste endoproteeside ost. 1.2. Pakkumuste esitamise tähtpäev on 19.06.2025. 1.3. TK on vastuolus riigihangete seaduse (RHS) § 88 lg-ga 7 ja RHS § 3 p-dega 1—3 ja 5. Riigihanke osades 1, 2, 3, 4, 5, 6, 7, 10, 11 ja 13 on hankija koostanud TK nii, et neile vastab kindel toode. OneMed OÜ (vaidlustaja) osalemine riigihankes on põhjendamatult takistatud. Ülejäänud riigihanke osades on tingimused ebaselged, mistõttu pole vaidlustajal võimalik aru saada, kas tema pakutavad tooted tingimustele vastavad või mitte, või ebaproportsionaalsed. 1.4. Vaidlustaja taotleb riigihangete vaidlustuskomisjonilt (VAKO) kohustada hankijat viima TK õigusaktidega kooskõlla (RHS § 185 lg 2 p 1). 2. RIIGIHANKE PEATAMISE TAOTLUS 2.1. VAKO võib vaidlustaja põhjendatud taotluse alusel teha igas vaidlustusmenetluse staadiumis otsuse riigihanke peatamise kohta (RHS § 193 lg 1). Vaidlustaja taotleb riigihanke peatamist kõikides riigihanke osades, kuna kõikides osades on õigusvastaseid tingimusi, mis vaidlustaja õiguseid riivavad. Riigihanke peatamine on põhjendatud, kuna pakkumuste esitamise tähtpäev saabub enne VAKO otsuse tegemist (RHS § 200 lg 1).1 2.2. Vaidlustuse eesmärk on saavutada olukord, kus hankija kehtestaks õigusvastaste hanketingimuste asemel õiguspärased tingimused. Sellise eesmärgi saavutamine ei ole enam võimalik, kui pakkumused on esitatud. Kui pakkumuste esitamise tähtaeg möödub, on RHADis sätestatud tingimused kohustuslikud nii hankijale kui pakkujatele, kellel tuleb edasises menetluses nendest tingimustest lähtuda. VAKO ega kohus ei saa kohustada hankijat pärast pakkumuste esitamise tähtpäeva möödumist RHADi muutma.2 Vaidlustaja on valmis taotlusest loobuma, kui hankija soostub ise pakkumuste esitamise tähtpäeva edasi lükkama nii, et tagatud oleks VAKO otsuse tegemine ja ka kaebetähtaeg. 1 VAKO 93-18/194960, p 4. 2 TlnRKm 3-15-1817, p 10; VAKO 166-17/190812, p-d 8, 11—14; VAKO 187-17/192426, p-d 8, 11—14. 3/13 3. PÕHJENDUSED 3.1. Vaidlustaja vaidlustab tingimusi kahel põhjusel. Esiteks, TK on koostatud kindlate toodete järgi (ptk A). Teiseks, TK on ebaselge (ptk 3.6). A. TEHNILINE KIRJELDUS ON KOOSTATUD KINDLATE TOODETE JÄRGI 3.1. Hankija on koostanud TK-d vaidlustatud osades kindlate toodete spetsifikatsioonide järgi (täpsemalt toodud allolevas tabelis). TK-d tervikuna lugedes on selge, et hankija on lihtsalt kopeerinud TK-sse nende toodete omadused. 3.2. Riigihangete korraldamise üheks üldpõhimõtteks on konkurentsi efektiivne ärakasutamine (RHS § 3 p 3). Hankija on vaidlusaluse riigihanke kirjutanud n-ö lukku nendele pakkujatele, kes pakuvad neid tooteid, mille omadusi on TK-s kirjeldatud. TK ei tohi aga tekitada objektiivselt põhjendamatuid takistusi riigihangete avamisel konkurentsile (RHS § 88 lg 7). TK ei tohi olla koostatud nii, et tingimustele vastaks üksnes üks toode või pakkuja.3 3.3. Hanketingimused peavad olema põhjendatud. Praegune TK, millega suunatakse hankeleping kindlate toodete pakkujatele, kindlasti põhjendatud ei ole. Hankija ei tohi seada hankelepingu eset silmas pidades põhjendamatuid piiranguid, mis välistavad ausa ja läbipaistva konkurentsi või on mõistliku põhjenduseta piiravad. 4 Hanketingimus ei tohi minna kaugemale, kui riigihankes taotletava eesmärgi saavutamiseks on mõistlikult vajalik.5 3.4. Vaidlustaja juhib tähelepanu, et 2021. aastal korraldas hankija endoproteeside riigihanke (238201) sarnase ülesehitusega ja tulemuseks oli olukord, kus hankija maksis endoproteeside eest 4 aasta jooksul ebamõistlikult kõrget hinda võrreldes samade või paremate tulemustega Eestis kasutatavate endoproteesidega. Hankija tegevus ei vasta seega ka üldpõhimõttele kasutada rahalisi vahendeid säästlikult ja otstarbekalt (RHS § 3 p 5). 3.5. Allolevas tabelis on välja toodud tingimused, mis takistavad vaidlustajal pakkumust esitamast. Paremalt teises lahtris on viide dokumendile, millest nähtub, et hankija valitud tootel on olemas täpselt kehtestatud nõudele vastav omadus. Parempoolses lahtris selgitab vaidlustaja, miks ei ole nõuded sellised kujul põhjendatud. TK Viide hankija valitud Miks ei ole tingimus TK punkti sisu punkt tootele põhjendatud Osa 4: Põlveliigese kondülaarne protees tagumise ristatisideme säilitamisega Hankija nõuded kirjeldavad OÜ Wimberg poolt müüdava Waldemar Link tooteid „SymphoKnee“ ja „Gemini SL“ kombinatsioonis veel mõne Waldemar Linki tootega, mille edasimüügiõigus on vaid OÜ-l Wimberg. 3 „Reieluu ja sääreluu Dokument „SymphoKnee Nõue on objektiivselt komponentide väljavõte“ (lisa 1) põhjendamatu ja valitud kindla suuruse ühilduvus toote järgi. Kõigil tootjatel on vähemalt +/- 2 omad kombineeritavuse tabelid, suurust.“ mis täidavad samaväärselt hankija eesmärki. 3 TlnRnKo 3-10-3225, p 18. 4 TlnHKo 3-20-582, p 12. 5 VAKO 34-19/206183, p 15. 4/13  4.1 “mobiilse ja Dokument „Gemini SL Nõue on objektiivselt toestatud kande surgical technique“ (lisa põhjendamatu ja valitud kindla komponendid;” 2), lk 2 toote järgi. Mobiilne kanne võib käia roteeruva tibia platoo mõistena, mitte reieosa komponendi nõudena. 5.1 “mobiiline kanne ja Dokument „Gemini SL Nõue on objektiivselt fikseeritud kanne;” surgical technique“ (lisa põhjendamatu ja valitud kindla 2), lk 2 toote järgi. Mobiilse kande nõude eesmärk on füsioloogiline liigese rotatsioon, eri tootjad lahendavad seda erinevalt süsteemipõhiselt, näiteks mediaalselt roteeruv protees. See täidab samaväärselt hankija eesmärki. 6.1 „Ülikõrge Dokument „Link Nõue on objektiivselt molekulmassiga Symphoknee Surgical põhjendamatu ja valitud kindla polüetüleenist technique“ (lisa 3), lk 65 toote järgi. Laialtlevinud standard (UHMWPE) on HXLPE või tootjaspetsiifiline liugpinnad.“ variant, mis täidab samaväärselt või paremini hankija eesmärki. UHMWPE materjal antud nõude kombineerimisel ülejäänud nõuetega on konkurentsi välistav. Osa 6: Erikonstruktsiooniga tsemeneteeritav põlveprotees Hankija nõuded kirjeldavad OÜ Ortolink Invest poolt müüdavat Smith & Nephew toodet „Primary Knee System“. 6.1 „reisosa materjal Dokument „OXINIUM- “Keramiseeritud metall” on üks keramiseeritud Knee-Brochure“ (lisa 4), võimalustest lahendada metall (ZrNb), et lk 4 probleemi, mis esineb 1-l sobiks ka patsiendil 100st (metalliallergia). metalliallergiaga Tegemist on Smith & Nephew patsientidele“ patenteeritud tehnoloogiaga (OXINIUM). On olemas ka alternatiive, nt Ti-Nidium, mis täidavad samaväärselt hankija eesmärki. 8.1 “plastikosa igal Dokument „Legion TKS „High flex insert“ on nimetus, mida mõõdul vähemalt 9 surgical technique“ (lisa kasutab ainult Smith & Nephew erinevat kõrgust, 5), lk 46 oma plastikosade kirjeldamiseks. high flex ja Teised tootjad võivad selle constrained tingimuse eesmärki täita näiteks variandid;” erilise disainiga reie komponendiga. 5/13 8.2 “vähemalt 6 Dokument „Legion TKS Nõue on objektiivselt erinevat surgical technique“ (lisa põhjendamatu ja valitud kindla polüetüleenist 5), lk-d 59 ja 61 toote järgi. Enamik süsteeme liigestuva pinna algab suurusest 10mm, mis suurust, CCK täidab samaväärselt hankija versioonil eesmärki. paksusega alates 9 mm;” 9.2 „Monteeritavad Dokument „Legion TKS Nõue objektiivselt põhjendamatu intramedullaarsed surgical technique“ (lisa ja valitud kindla toote järgi. Igal pikendused: varre 5), lk 59 tootjal on oma suuruste ja pikendused alates pikkustega varred, mis vastavad diameetrist 10 mm, süsteemile ja täidavad pikkusega vähemalt samaväärselt hankija eesmärki. vahemikus 80 mm – 275 mm, sirged. Tsemendivabad ja tsemendiga versioonid.“ 9.3 “Revisjonvarred: Dokument „Legion TKS Nõue on objektiivselt pikendused koos surgical technique“ (lisa põhjendamatu ja valitud kindla mõõdetava Offset- 5), lk 59 toote järgi. Igal tootjal on oma ga , alates suuruste ja pikkustega varred, mis diameetrist 9 mm ja vastavad süsteemile ja täidavad pikkusega vähemalt samaväärselt hankija eesmärki. vahemikus 120 – 270 mm. Nii tsementeeritavad kui tsemendivabad.” 9.6 „Põlvekedra Dokument „Legion TKS Nõue on objektiivselt protees: vähemalt surgical technique“ (lisa põhjendamatu ja valitud kindla kolme erineva 5), lk 48 toote järgi. Igal tootjal on oma kujuga ja vähemalt suuruste ja variatsioonidega 6 erineva põlvekedra proteesid, mis paksusega.“ vastavad süsteemile ja täidavad samaväärselt hankija eesmärki. Osa 10: Mittetsemeneteeritav puusaprotees (põhiproteesina) Hankija nõuded kirjeldavad OÜ Ortolink Invest poolt müüdavaid Smith & Nephew tooteid „SL Plus MIA“ ja „R3“ kombinatsioonis veel mõne Smith & Nephew tootega, mille edasimüügiõigus on vaid OÜ-l Ortolink Invest. 1.5 “reieosa 2 erineva Dokument „SL PLUS Nõue on objektiivselt kaela nurgaga- MIA Surgical technique“ põhjendamatu ja valitud kindla standard (131°) ja (lisa 6), lk 16 toote järgi (täpselt 131°). Vaidlustaja toote puhul on reieosa 6/13  lateraliseeritud 2 erineva kaela nurgaga: standard (123°);” (133°) ja lateraliseeritud (123°). See täidab hankija eesmärki samaväärselt. 1.6 ”reieosa kaela Dokument „SL PLUS Nõue on objektiivselt pikkus standard MIA Surgical technique“ põhjendamatu ja valitud kindla varrel 17-49mm ja (lisa 6), lk 17 toote järgi (täpselt 17-49mm ja lateraliseeritud 26-58mm). Vaidlustaja toote puhul variandil 26-58mm” on reieosa kaela pikkus standard varrel 28,3-49,4mm ja lateraliseeritud variandil 33,6- 54,6mm. See täidab hankija eesmärki samaväärselt. 2.5 ”napa sisemine - Nõue on objektiivselt vooder saadaval nii põhjendamatu. PE vooder on PE kui XLPE vananenud tehnoloogia. Kuna PE variandis;” voodriga implantaatide kliinilised tulemused on kehvemad kui näiteks XLPE versioonil, siis ei paku enamik vastutustundlikuid tootjad enam PE versiooni. Kuna hankija nõuab nii üht kui teist, teeb hankija võimatuks XLPE variandis tooteid pakkuda (mis ei täida hankija eesmärki isegi samaväärselt, vaid paremini). 2.8 „Pressfit napaosa Dokument „R3 Surgical Nõue on objektiivselt suurused 40mm – technique“ (lisa 7) lk-d 13 põhjendamatu ja valitud kindla 80 mm millele ja 17. toote järgi. 0° ja 10° sobivad XLPE kõrgendusega on saavutatav plastikosad 0° ja samaväärne tulemus, mis 0° ja 20° kõrgendusega;“ 20° kõrgendusega. 3.1 „reiepea materjal Dokument „OXINIUM- „Keramiseeritud metall” on Smith keramiseeritud Knee-Brochure“ (lisa 4), & Nephew patenteeritud metall (ZrNb);“ lk 4 tehnoloogia (OXINIUM). On olemas ka alternatiive, nt Ti- Nidium, mis täidavad samaväärselt hankija eesmärki. Osa 11: Mittetsemeneteeritav puusaprotees (alternatiiv) Hankija nõuded kirjeldavad OÜ Wimberg poolt müüdavat Waldemar Link toodet „SP- CL“ kombinatsioonis veel mõne Waldemar Link tootega, mille edasimüügiõigus on vaid OÜ-l Wimberg. 7/13  1.1 ”bioloogiliselt/anato Dokument „SP-CL Nõue on objektiivselt omiliselt sobilik, Product Rationale“ (lisa põhjendamatu. S-kõverus on mille S-kõverus 8), lk 3 ainult Waldemar Linki toodetele järgib reieluu omane omadus. Samaväärseid loomulikku või paremaid kliinilisi tulemusi on anatoomilist kuju;” võimalik saavutada ka teiste kujudega proteesidega. 1.2 ”Vasaku ja parema Dokument „SP-CL Vasak ja parem versioon on poole versioonid” Anatomically Adapted vajalikud anatoomilise disaini Cementless Hip System“ puhul. Samaväärsete või (lisa 9), lk 3 paremate tulemustega teise disainiga vartel ei ole vaja vasakut ja paremat versiooni. 1.6 ”Kahe CCD nurga Dokument „SP-CL Nõue on objektiivselt võimalus – 126 ja Anatomically Adapted põhjendamatu ja valitud kindla 135 kraadi” Cementless Hip System“ toote järgi (täpselt 126 ja 135 (lisa 9), lk 3 kraadi, nagu Waldemar Link tootel). 1.7 ”Reieosal vähemalt Dokument „SP-CL Vasak ja parem versioon on 18 erinevat suurust Anatomically Adapted vajalikud anatoomilise disaini vasakule ja Cementless Hip System“ puhul. Samaväärsete või paremale” (lisa 9), lk 3 paremate tulemustega teise disainiga vartel ei ole vaja vasakut ja paremat versiooni. 2.4 ”napaosa võimalik - Nõue on objektiivselt modulaarsete põhjendamatu ja valitud kindla komponentidega toote järgi. 0° ja 10° 10° ja 20° serva kõrgendusega on saavutatav kõrgendada” samaväärne tulemus, mis 0° ja 20° kõrgendusega. 3.6. Lisaks eelnevale vaidlustab vaidlustaja TK-sid tervikuna osades 1, 2, 3, 5, 7 ja 13. Riigikohus on selgitanud, et tingimuste kogum on õigusvastane, kui selle eesmärk on ebakohastel eesmärkidel konkreetse ettevõtja soosimine.6 Viidatud osade TK-d on kogumis koostatud nii, et neile vastavad vaid ühe tootja tooted: a. Osa 1 („tsementeeritav standardne puusaprotees (põhiproteesina)“) nõuded kirjeldavad OÜ Wimberg poolt müüdavat Waldemar Link toodet „Lubinus SPII“ kombinatsioonis veel mõne Waldemar Link tootega, mille edasimüügiõigus on vaid OÜ-l Wimberg. b. Osa 2 („tsementeeritav standardne puusaprotees (alternatiivse proteesina)“) nõuded kirjeldavad OÜ Ortolink Invest poolt müüdavaid Smith & Nephew tooteid „Polar Stem“ ja „Polar Cup“ kombinatsioonis veel mõne Smith & Nephew tootega, mille edasimüügiõigus on vaid OÜ-l Ortolink Invest. c. Osa 3 („puusaliigese eriprotees“) nõuded kirjeldavad OÜ Wimberg poolt müüdavat Waldemar Link toodet „Link MP Reconstruction“ kombinatsioonis veel mõne Waldemar 6 RKHKo 3-20-718, p 18. 8/13  Link tootega, mille edasimüügiõigus on vaid OÜ-l Wimberg. d. Osa 5 („tsemeneteeritav põlveprotees tagumise ristatisideme stabiliseerimisega“) nõuded kirjeldavad Johnson&Johnson AB Eesti filiaali poolt müüdava DePuy Synthese toodet „Attune“. e. Osa 7 („põlveliigese eriprotees“) nõuded kirjeldavad OÜ Wimberg poolt müüdava Waldemar Link põlveproteesi kombinatsioonis veel mõne Waldemar Link tootega, mille edasimüügiõigus on vaid OÜ-l Wimberg. f. Osa 13 („megaprotees“) nõuded kirjeldavad OÜ Wimberg poolt müüdava Waldemar Link tooteid. Eriti ilmselt avaldub see tõsiasi TK punktis 5, kus nõuab hankija, et pakutav toode peab olema kombineeritav põlveliigese Endo-model põlve implantaadi ning puusaliigese MP rekonstruktsiooni proteesiga. Tegemist on Waldemar Link toodetega. Lisaks, Eestis on erinevatel tootjatel oluliselt kaasaegsemaid lahendusi, mille kliinilised tulemused on paremad kui mainitud Endo-model proteesil. B. TEHNILINE KIRJELDUS ON EBASELGE 3.7. Teatud TK tingimusi vaidlustab vaidlustaja ka põhjusel, et nende sisu on ebaselge ning seega vastuolus läbipaistvuse põhimõttega (RHS § 3 p 1). Vaidlustajal ei ole nende tingimuste sisu ebaselguse tõttu võimalik aru saada, kas tema pakutavad tooted tingimustele vastavad või mitte. 3.8. Vaidlustaja hinnangul on hankija teadlikult koostanud segaste ning asjatundmatute mõistetega, tihti omavahel vastuolevad tingimused, et varjata soovi osta kindlaid tooteid kindlatelt edasimüüjatelt. TK punkt TK punkti sisu Miks on tingimus ebaselge Osa 7 TK punkt „Peab ühilduma Pakkujal pole võimalik aru saada, millega 8 megaproteesi (osa 13) peab osas 7 hangitav põlveliigese komponentidega.“ eriprotees ühilduma. See, millist toodet hankija osa 13 („megaprotees“) raames hangib, sõltub sellest, milline pakkumus osutub edukaks. Pakkumuse esitamise hetkel ei ole olemas „megaproteesi (osa 13) komponente“, millega oleks üldse ühilduda võimalik. Jääb mulje, nagu hakkab hankija osas 7 kontrollima pakkumuste vastavust selle alusel, milline pakkumus osutus edukaks osas 13. Selline teguviis on ilmselgelt õigusvastane. Lisa 24 Esitada tuleb „reiepea Osas 2, millega pakkumuse maksumuse (pakkumuse komplekti“ hind. vormi (lisa 24) punkt 2.3 korreleerub, ei maksumuse ole sellist asja nagu „reiepea komplekt“. tabel), punkt 2.3 Tsemendilise puusaproteesi varre külge ei paigaldata komplekte, vaid reiepäid. Terminist “reiepea komplekt” võib aru saada kui mitmest osast koosnevast lahendusest, mis on oluliselt kallim tavapärasest reiepeast. Hankija on teabevahetuses kinnitanud, et tegemist 9/13  on „inimliku eksimusega“ ja ta peab silmas reiepead, kuid ei ole hankedokumente parandanud. Hankijal ei ole võimalik teabevahetuse teel hankedokumente muuta. Maksumuse vormi ebaselgus võib põhjustada pakkumuste tagasi lükkamise või maksumuste võrreldamatuse. Osade 1—4 ja TK-des on osad nõuded Ebaselgeks jääb, mida need nõuded 10 TK-de liigitatud kui „Muud endast kujutavad – kas tegemist on peatükid „Muud täiendavad komponendid“, kohustusliku nõuetega või mitte. täiendavad „Lisavahendid“, „Teised Dokumendi „Juhised pakkujale“ p-s 1.4 komponendid“ lisavõimalused“, on kirjutatud, et mistahes dokumendis „Lisavõimalused“, „Muud sätestatud kohustus, tingimus või nõue Osade 3–4 TK- täiendavad komponendid ja on pakkujale kohustuslik. Sama de peatükid võimalused“. dokumendi p-s 6.9 on kirjas, et „Lisavahendid“ pakutavad tooted peavad vastama Osade 4—7 TK- kõikidele TK-s esitatud nõuetele. See on de peatükid ka loogiline, kuna tehniline kirjeldus on „Teised „asjade omaduste ja neile esitatavate lisavõimalused“ nõuete loetelu“ (RHS § 87 lg 1 p 1). Osade 5—7 TK- Teabevahetuses (ID 972062) on hankija de peatükid aga andnud teada, et n-ö lisanõuete „Lisavõimalused“ täitmine pole siiski kohustuslik: „Need ei ole kohustuslikud, kuid kui pakkujal on Osade 6—9 TK- neid pakkuda, peavad need olema de peatükid sobivad ja ühilduvad nõutud „Muud implantaatidega.“ Hankija ei saa täiendavad teabevahetuse kaudu muuta komponendid ja kohustuslikku tingimust vabatahtlikuks võimalused“ (RHS § 46 lg 3). Hankija ei ole lubanud alternatiivsete pakkumuste esitamist („Juhised pakkujale“ p 3.4). Ka praktilises mõttes jääb täiesti arusaamatuks, kuidas saavad olla teatud TK nõuded iseloomuga „kui pakkujal on pakkuda, siis paku“. Hankija peab hanketingimusi muutma, et sellest tuleneks üheselt selgelt, kuidas pakkujad peavad n-ö lisanõuete osas käituma. Ebaselgus võib põhjustada pakkumuste tagasi lükkamise või maksumuste võrreldamatuse. Seejuures on ilmselgelt asjakohatu hankija põhjendus, justkui võimaldavad lisavõimalused „saada pakkumusi laiemalt“, arvestades et hankija on TK-d kirjutanud lukku kindlatele toodetele. Osade 1—14 „Endoproteesi komplekti Jääb arusaamatuks, miks on vaja TK-de baashinna arvutamiseks endoproteesi komplekti baashinda. Mitte tingimused, mis liidetakse kõige enam kusagil mujal hanketingimustes ei ole 10/13  algavad kasutatavate mõõtudega reie, viidet endoproteesi komplekti sõnadega sääre ja liigespinna baashinnale. Millise metoodika järgi „Endoproteesi komponentide hinnad.“ liidetake kõige enam kasutatavate komplekti mõõtudega reie, napa ja reiepea baashinna komponentide hinnad ja miks seda vaja arvutamiseks on? Kust tuleb sisend „enim kasutatavate /…/“ mõõtude jaoks“? Pole aru saada, millele pakkuja selles tingimuses kinnituse annab. Osade 1—23 Jääb arusaamatuks, mida tähendab TK-de instrumentide komplekti “tagamine”. „Pakkuja peab hankijale tingimused, mis Endoproteeside valdkonnas on tagama spetsiifiliste algavad tavapärane, et hanke võitja annab instrumentide komplektid, sõnadega instrumentide komplekti(d) tasuta mille maksumus on arvutatud „Pakkuja peab kasutamiseks. Kui tegemist on väga vähe implantaatide osana (nn hankijale kasutatavate implantaatidega, siis on ka garanteeritud instrumentide tagama võimalus, et hankija ostab instrumentide komplektid).“ spetsiifiliste komplekti välja. Sõnakasutus „tagama“ instrumentide põhjustab ebaselgust, millele pakkuja komplektid /…/“. oma kinnituse andma peab. „Tagama“ viitab sellele, et pakkujal peab olema teoreetiline võimekus komplekte hankijale tarnida, mitte ei pea ta neid kindlasti tarnima. Osade 1—23 „Garanteeritud instrumentide Jääb arusaamatuks, mida tähendab TK-de komplektide arv arvestatakse “garanteeritud instrumentide komplekt”. tingimused, mis 1 komplekt/100 endoproteesi Mujal hanketingimused eristata algavad täiskomplekti kohta.“ „garanteeritud“ ja „garanteerimata“ sõnadega komplekte. Valdkonnas väljakujunenud „Lisaks garanteeritud „Garanteeritud tava on, et instrumendid kas antakse instrumentide komplektidele instrumentide tasuta kasutamiseks või hankija ostab on hankijal õigus instrumente komplektide arv instrumendid välja või kasutatakse või komplekte ka täiendavalt arvestatakse laenuinstrumente (instrumendid tuuakse osta pakkumuses märgitud /…/“ ja „Lisaks kohale, kui hankija selleks soovi hindadega.“ garanteeritud avaldab). Pole aru saada, kes, kellele ja instrumentide mida garanteerib. komplektidele Samuti on arusaamatu hankija nõue /…/“. saada endale 1 komplekt garanteeritud instrumente 100 endoproteesi täiskomplekti kohta. Kui pakkuja kinnitab selle tingimusega nõustumust, peab ta olema valmis tarnima hankeperioodi jooksul kuni 20 komplekti instrumente ühe osa kohta. Tavapäraselt saab hankija hakkama 1—3 instrumentide komplektiga ühe hanke osa kohta kogu hankeperioodi jooksul (3—4 aastat). Kuna tegemist on sedavõrd tavatu (ja ebaselge) nõudega, 11/13  ei ole aru saada, millele pakkuja peab kinnituse andma. Täiendavat segadust tekitab punkt, millega hankija annab endale õiguse lisaks garanteeritud instrumentide komplektidele instrumente või komplekte ka täiendavalt osta pakkumuses märgitud hindadega. Mis mahus, mis tingimustel ja mis alusel hankija lisatellimusi esitama hakkab? Kuna juba mõiste „garanteeritud instrumentide komplektid“ on ebaselge, pole aru saada, millele pakkuja peab kinnituse andma. Instrumentide vajadus ja nende tarnimise tingimused peavad olema selged. C. TEHNILINE KIRJELDUS ON EBAPROPORTSIONAALNE 3.9. Viimaks vaidlustab vaidlustaja dokumendi „Juhised pakkujale“ punkte 6.18—6.18.2 ja 7.2: Punkt 6.18: „Hankijal on õigus nõuda pakkuja poolt pakutud toodete näidiseid koos paigaldamiseks vajalike instrumentidega nende toodete vastavuse tuvastamiseks (sh hankijale eesmärgipäraseks kasutamiseks sobivuse määramiseks) läbi funktsionaalsete omaduste praktilise testimise. Näidis peab olema originaalpakendis, varustatud toote koodi/ref.nr-ga, toote nimetusega ja vastava pakkumuse osa numbriga.“ Punkt 6.18.1: „Näidis tuleb viia L. Puusepa 8, Tartu, ortopeediakliiniku ortopeedia osakonda (ruum H 156) või saata postiga samale aadressile. Tellimuse täitmise tähtaeg on 7 (implantaadi näidis) või 14 (implantaadi näidis koos paigalduseks vajalike instrumentidega) kalendripäeva alates tellimuse esitamisest. Tellimuse mittetähtaegsel täitmisel tunnistatakse pakkumus mittevastavaks.“ Punkt 6.18.2. „Tootenäidiste maksumust ei hüvitata pakkujale. Näidise paigalduseks vajalikud instrumendid tagastatakse pakkujale pärast hankemenetluse lõppemist, testimise tarbeks kasutamise eest ei tasuta.“ Punkt 7.2: „Toodete vastavuse tuvastamiseks võib hankija vajadusel moodustada ekspertkomisjoni, kes hindab näidiste vastavust praktilise testimise teel. Toodete praktiline testimine protokollitakse. Kui toote praktilise testimise käigus ilmneb, et toode ei vasta kirjeldatud omadustele või kasutustehnoloogiale või esineb tehnilisi tõrkeid toote kasutamisel või toode ei täida ootuspäraselt eesmärki või omab varjatud puudusi, on hankijal õigus tunnistada pakkumus mittevastavaks.“ 3.10. Esiteks, tingimused on ebaproportsionaalsed (RHS § 3 p 1). Need nõuded annavad hankijale nt õiguse nõuda kõikide komponentide kõikide suuruste kohaletoomist. Primaarproteeside puhul tähendab selline nõue pakkujale orienteeruvalt 30—100 tuhande euro suurust kulutust. Revisioon- või megaproteesi puhul võivad summad ulatuda sadade tuhandeteni. Sealjuures peavad pakkujad suutma hankija nõude täita 7 või 14 kalendripäevaga. Olukorras, kus hankijal on võimalik toodete vastavust kontrollida tehnilise dokumentatsiooni alusel – vajaduse korral nõudes välja ka täiendavaid tõendeid –, on pakkumuste vastavuse kontrollimine sellisel viisil pakkujad ilmselgelt ebamõistlikult koormav. 3.11. Teiseks, tingimused on läbipaistmatud (RHS § 3 p 1). Ebaselgeks jääb, kelle käest asub pakkuja näidiste toomist nõudma. Vastavust tuleb kontrollida kõikide pakkumuste puhul (RHS § 114 lg 1). Tingimuste sõnastusest tulenevalt on hankijal aga õigus nõuda näidiste toomist vaid ühe pakkuja puhul, kusjuures nõude täitmata jätmine on eraldiseisev mittevastavuse alus ja sellega kaasnevat kulu pakkujale ei hüvitata. On ilmselgelt õigusvastane olukord, milles hankija kontrollib 12/13  pakkumuste vastavust erineval moel. Lisaks, kui pakkuja ei pea näidiste toomisega kaasnevat kulu äriliselt mõistlikuks (ja hankija teab seda), on hankijal sisuliselt võimalik tõrjuda hankemenetlusest pakkuja, kes talle ei sobi. Pingereas teise pakkuja puhul pole aga hankija kohustatud näidiste toomist nõudma, kuna tegemist on tema õigusega. 4. MENETLUSLIKUD KÜSIMUSED 4.1. Riigilõiv. Vaidlustaja on tasunud vaidlustuse eest riigilõivu 1280 eurot (RLS § 258 lg 1 p 2) (lisa 10). 4.2. Esindus. Vandeadvokaat Erki Fels ja vandeadvokaadi abi Gregor Saluveer kinnitavad, et on vaidlustaja lepingulised esindajad (RHS § 190 lg 11). 4.3. Tähtaegsus. Pakkumuste esitamise tähtpäev on 19.06.2025. Vaidlustus on tähtaegne (RHS § 189 lg 2 p 2). 4.4. Läbivaatamine. Vaidlustaja on nõus kirjaliku menetlusega (RHS § 190 lg 1 p 6). 4.5. Esitamine. Vaidlustus on esitatud VAKO-le e-posti teel ([email protected]). Lugupidamisega (digitaalselt allkirjastatud) Erki Fels, Gregor Saluveer, vandeadvokaat vandeadvokaadi abi LISAD Lisa 1 SymphoKnee väljavõte Lisa 2 Gemini SL Surgical technique Lisa 3 Link SymphoKnee Surgical technique Lisa 4 OXINIUM-Knee-Brochure Lisa 5 Legion TKS Surgical technique Lisa 6 SL PLUS MIA surgical technique Lisa 7 R3 Surgical technique Lisa 8 SP-CL Product Rationale Lisa 9 SP-CL Anatomically Adapted Cementless Hip System Lisa 10 Riigilõivu tasumist tõendav maksekorraldus 13/13