510(k) Report

Devices descending from K951987

254 later devices reach Genesis II Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+1K221939Cemented Round Patella with JRNY PegsSmith & Nephew, Inc.20220—
+1K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+1K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+1K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc.20174—
+1K162775Legion Cone SystemSmith & Nephew, Inc.201752
+1K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+1K150241Genesis II XLPE Resurfacing Patellar ComponentsSmith & Nephew, Inc.20150—
+1K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+1K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc.20147—
+1K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+1K140073U2 Femoral Component, CR, CementedUnited Orthopedic Corp.20144—
+1K131310GMK Full PE Tibial ComponentsMedacta International20132—
+1K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+1K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+1K120698Genesis II PS Non-Modular Femoral ComponentSmith & Nephew, Inc.20120—
+1K120507United U2 Femoral Component, PS, #7United Orthopedic Corporation201241
+1K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126—
+1K113571GMK Resufacing Patella Size 4Medacta International201223—
+1K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral ComponentsSmith & Nephew, Inc.201183
+1K111711Journey II BCS Knee SystemSmith & Nephew, Inc.2011403
+1K102367Optigen Total Knee SystemU&I Corp.20100—
+1K101499Journey CR Knee SystemSmith & Nephew, Inc.201045—
+1K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp.2009421
+1K073325Legion Porous PrimarySmith & Nephew, Inc.200750—
+1K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc.2007665
+1K042515Smith & Nephew, Inc. High Performance KneeSmith & Nephew, Inc.20051183
+1K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc.200575—
+1K043440Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc.2005317
+1K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc.2003766
+1K030612Genesis II Total Knee SystemSmith & Nephew, Inc.2003141—
+1K981560Implex Continuum Knee System: Porous Tibial Component Model Number 05-230 SystemImplex Corp.19980—
+2K262057GMK ExtensionMedacta International SA20260—
+2K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+2K230555Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc.20230—
+2K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+2K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG20220—
+2K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+2K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+2K210062Mectaplug PE IIMedacta International S.A.20210—
+2K210566LEGION Porous CR Narrow Femoral ComponentsSmith & Nephew, Inc.20210—
+2K201084Physica systemLima Corporate S.P.A.20205—
+2K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+2K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+2K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+2K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+2K190577World Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd.20195—
+2K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+2K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+2K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+2K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+2K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+2K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+2K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+2K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+2K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+2K151118Smith and Nephew Legion Hinge Knee SystemSmith & Nephew20154—
+2K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+2K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+2K140075U2 Femoral Component, CR, Porous CoatedUnited Orthopedic Corp.20143—
+2K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+2K123692Pipeline Knee SystemPipeline Orthopedics20130—
+2K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+2K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+2K121416GMK SphereMedacta International201220—
+2K112906Klassic Knee SystemTotal Joint Orthopedics, Inc.201233—
+2K110837Revision ProthesisSmith & Nephew, Inc.20110—
+2K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+2K103837Balanced Knee System Revision Offset TibiaOrtho Development20110—
+2K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110—
+2K094050Itotal CR Knee Replacement SystemConformis, Inc.201041—
+2K100981United Stem, Psa TypeUnited Orthopedic Corp.20103—
+2K093746Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc.201029—
+2K091543Legion Porous Plus HA Primary Femoral ComponentsSmith & Nephew, Inc.20097—
+2K091014Journey BCS Knee SystemSmith & Nephew, Inc.200941—
+2K060742Legion Cobalt Chrome Revision Knee SystemSmith & Nephew, Inc.2006103
+2K053390Columbus (CR) Total Knee SystemAesculap, Inc.200651
+2K052265Smith & Nephew Competitor Duo Knee FemoralSmith & Nephew, Inc.2005242
+2K051229Profix Flex Cruciate Retaining Articular InsertSmith & Nephew, Inc.200514—
+2K033489Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim…Biomet, Inc.200460—
+2K032683Genesis II Porous Plus HA Knee SystemSmith & Nephew, Inc.200319—
+3K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+3K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+3K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+3K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+3K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+3K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+3K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+3K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+3K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+3K221705U2 Total Knee System-PF+United Orthopedic Corporation20231—
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+3K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+3K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+3K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal…Signature Orthopaedics Pty, Ltd.20224—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K211664GMK Sphere RevisionMedacta International S.A.20210—
+3K211602Klassic Knee SystemTotal Joint Orthopedics, Inc.20210—