510(k) Report

Devices descending from K042515

118 later devices reach Smith & Nephew, Inc. High Performance Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+1K221939Cemented Round Patella with JRNY PegsSmith & Nephew, Inc.20220—
+1K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+1K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+1K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+1K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126—
+1K111711Journey II BCS Knee SystemSmith & Nephew, Inc.2011403
+1K110837Revision ProthesisSmith & Nephew, Inc.20110—
+1K094050Itotal CR Knee Replacement SystemConformis, Inc.201041—
+1K101499Journey CR Knee SystemSmith & Nephew, Inc.201045—
+1K091014Journey BCS Knee SystemSmith & Nephew, Inc.200941—
+1K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc.2007665
+2K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+2K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+2K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+2K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+2K230555Cemented Tibia Baseplate no Taper with JRNY LockSmith & Nephew, Inc.20230—
+2K220896Legion Inserts with JRNY LockSmith & Nephew, Inc.20221—
+2K213381Physica systemLima Corporate S.P.A.202101
+2K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+2K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+2K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+2K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+2K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+2K123692Pipeline Knee SystemPipeline Orthopedics20130—
+2K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+2K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+2K122991Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+2K122033Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+2K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+2K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+2K113378Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+2K120068Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc.201236—
+2K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201138—
+2K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+2K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2011401
+2K093746Verilast Wear Claims for the Legion Primary Knee SystemSmith & Nephew, Inc.201029—
+3K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+3K211938Physica LMC Knee SystemLimacorporate20210—
+3K201084Physica systemLima Corporate S.P.A.20205—
+3K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+3K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+3K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+3K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+3K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+3K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+3K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+3K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+3K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+3K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+3K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+3K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+3K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral ComponentsSmith & Nephew, Inc.201183
+4K210554Physica systemLima Corporate S.P.A.20212—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+4K170648ANTHEM CR Total Knee SystemSmith & Nephew, Inc.20174—
+4K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+4K152726JOURNEY II XR Knee SystemSmith & Nephew, Inc.20154—
+4K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+4K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc.20147—
+4K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+4K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+5K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+5K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+5K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+5K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+5K150241Genesis II XLPE Resurfacing Patellar ComponentsSmith & Nephew, Inc.20150—
+5K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+5K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+6K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K230078TRAX® CR Total Knee SystemAmplitude20230—
+6K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+6K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+6K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—