510(k) Report

Devices descending from K953274

161 later devices reach Genesis Porous Tibial Trays & Revision Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+4K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+4K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+4K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120—
+4K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral ComponentsSmith & Nephew, Inc.201183
+4K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+5K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, 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—
+5K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+5K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+5K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+5K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+5K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+5K213381Physica systemLima Corporate S.P.A.202101
+5K211938Physica LMC Knee SystemLimacorporate20210—
+5K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+5K201611Apex Knee SystemOmnilife Science20210—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K191625Persona Revision Knee SystemZimmer, Inc.201911
+5K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+5K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+5K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+5K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+5K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+5K143635KINETIS Total Knee SystemMako Surgical20150—
+5K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc.20147—
+5K140257Signature Planner, Signature GuidesMaterialise NV20140—
+5K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K210551Persona Revision Knee SystemZimmer, Inc.202101
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+6K153437Apex Revision Knee SystemOmnilife Science201541
+6K150241Genesis II XLPE Resurfacing Patellar ComponentsSmith & Nephew, Inc.20150—
+7K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+7K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+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—
+7K230078TRAX® CR Total Knee SystemAmplitude20230—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+7K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+7K163332Apex Revision Knee SystemOmnilife Science20173—
+8K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+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—