510(k) Report

Devices descending from K962137

93 later devices reach Genesis II Constrained System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+1K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+1K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+1K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc.2007665
+1K043440Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc.2005317
+1K041106Revision Knee SystemSmith & Nephew, Inc.2004321
+2K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+2K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+2K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+2K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+2K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+2K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+2K151118Smith and Nephew Legion Hinge Knee SystemSmith & Nephew20154—
+2K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+2K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+2K111711Journey II BCS Knee SystemSmith & Nephew, Inc.2011403
+2K103837Balanced Knee System Revision Offset TibiaOrtho Development20110—
+2K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110—
+2K100981United Stem, Psa TypeUnited Orthopedic Corp.20103—
+2K093746Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc.201029—
+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
+3K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+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—
+3K230555Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc.20230—
+3K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+3K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG20220—
+3K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+3K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+3K190100USTAR II SystemUnited Orthopedic Corporation201925
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+3K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+3K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+3K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126—
+3K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral ComponentsSmith & Nephew, Inc.201183
+3K061569Smith & Nephew Competitor Deuce Femoral ComponentsSmith & Nephew, Inc.20061—
+4K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+4K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc.20174—
+4K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+4K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc.20147—
+4K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+4K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120—
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+5K201611Apex Knee SystemOmnilife Science20210—
+5K201084Physica systemLima Corporate S.P.A.20205—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+5K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+5K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+5K150241Genesis II XLPE Resurfacing Patellar ComponentsSmith & Nephew, Inc.20150—
+5K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+5K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+6K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+6K230078TRAX® CR Total Knee SystemAmplitude20230—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K213381Physica systemLima Corporate S.P.A.202101
+6K211938Physica LMC Knee SystemLimacorporate20210—
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+7K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+7K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+7K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+7K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+7K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—