510(k) Report

Devices descending from K962557

130 later devices reach Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+1K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral ComponentsSmith & Nephew, Inc.201183
+1K093746Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc.201029—
+1K071220Columbus Total Knee System asAesculap Implant Systems, Inc.200771
+1K052265Smith & Nephew Competitor Duo Knee FemoralSmith & Nephew, Inc.2005242
+1K042515Smith & Nephew, Inc. High Performance KneeSmith & Nephew, Inc.20051183
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+2K221939Cemented Round Patella with JRNY PegsSmith & Nephew, Inc.20220—
+2K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+2K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+2K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc.20174—
+2K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+2K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+2K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+2K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc.20147—
+2K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+2K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+2K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+2K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126—
+2K111711Journey II BCS Knee SystemSmith & Nephew, Inc.2011403
+2K110837Revision ProthesisSmith & Nephew, Inc.20110—
+2K094050Itotal CR Knee Replacement SystemConformis, Inc.201041—
+2K101499Journey CR Knee SystemSmith & Nephew, Inc.201045—
+2K091014Journey BCS Knee SystemSmith & Nephew, Inc.200941—
+2K081293Univation Unicondylar Knee SystemAesculap Implant Systems, Inc.200818
+2K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc.2007665
+2K061569Smith & Nephew Competitor Deuce Femoral ComponentsSmith & Nephew, Inc.20061—
+3K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+3K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+3K230555Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc.20230—
+3K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+3K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+3K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+3K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+3K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+3K150241Genesis II XLPE Resurfacing Patellar ComponentsSmith & Nephew, Inc.20150—
+3K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+3K131167UnivationAesculap Implant Systems, LLC201308
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+3K122991Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+3K122033Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+3K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+3K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+3K113378Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+3K120068Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc.201236—
+3K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120—
+3K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201138—
+3K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+3K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2011401
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K201611Apex Knee SystemOmnilife Science20210—
+4K201084Physica systemLima Corporate S.P.A.20205—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+4K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+4K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+4K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+4K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+4K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+4K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+4K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+4K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K230078TRAX® CR Total Knee SystemAmplitude20230—
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K210554Physica systemLima Corporate S.P.A.20212—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+5K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+5K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+5K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+5K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+5K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+5K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+6K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+6K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+6K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973