510(k) Report

Devices descending from K951987

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K211938Physica LMC Knee SystemLimacorporate20210—
+3K211246LEGION CR Porous Plus HA Femoral ComponentsSmith & Nephew, Inc.20210—
+3K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+3K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+3K210554Physica systemLima Corporate S.P.A.20212—
+3K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+3K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+3K190100USTAR II SystemUnited Orthopedic Corporation201925
+3K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+3K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+3K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+3K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+3K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+3K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+3K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+3K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+3K162035GMK SphereMedacta International S.A.201710—
+3K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+3K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+3K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+3K153310Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+3K153075Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+3K150832U2 Femoral Component, CR, Porous Coated, Additional SizesUnited Orthopedic Corporation20152—
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.201524—
+3K142933Biomet Tibial traysBiomet, Inc.201463
+3K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+3K142069GMK ExtensionMedacta International20144—
+3K140826GMK Sphere ExtensionMedacta International201417—
+3K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+3K133630GMK Short StemMedacta International20131—
+3K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+3K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+3K122991Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+3K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+3K122033Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201226—
+3K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+3K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+3K113378Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201236—
+3K120068Conformis Itotal CR Knee Replacement System (KRS)Conformis, Inc.201236—
+3K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201138—
+3K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+3K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2011401
+3K100897Legion Porous + HA Tibial BaseplatesSmith & Nephew, Inc.201012—
+3K080361Regenerex Tibial ComponentsBiomet, Inc.2008131
+3K061433Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveBiomet Manufacturing, Inc.20060—
+3K061569Smith & Nephew Competitor Deuce Femoral ComponentsSmith & Nephew, Inc.20061—
+3K060303Vanguard PS Open Box Porous Femoral ComponentsBiomet Manufacturing Corp200647—
+3K041872Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral PegsBiomet Manufacturing Corp20040—
+4K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+4K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+4K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+4K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+4K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+4K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+4K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+4K240683Rx Knee SystemSignature Orthopaedics Pty, Ltd.20242—
+4K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+4K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+4K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+4K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+4K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+4K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+4K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+4K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+4K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+4K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+4K181947Persona Revision Knee SystemZimmer, Inc.201841
+4K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+4K153657Vanguard XP Knee SystemBiomet, Inc.201611
+4K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+4K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+4K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+4K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+4K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+4K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+4K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+4K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+4K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120—
+4K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+5K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+5K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—