510(k) Report

Devices descending from K030612

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K143635KINETIS Total Knee SystemMako Surgical20150—
+4K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+4K140257Signature Planner, Signature GuidesMaterialise NV20140—
+4K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+4K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+4K112941Legion Narrow Oxinium Cruciate Retaining and Posterior Stabilized Fenoral ComponentsSmith & Nephew, Inc.201183
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+5K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+5K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+5K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+5K153437Apex Revision Knee SystemOmnilife Science201541
+5K142807ANTHEM PS Total Knee SystemSmith & Nephew, Inc.20147—
+6K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+6K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+6K163332Apex Revision Knee SystemOmnilife Science20173—
+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—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+7K230078TRAX® CR Total Knee SystemAmplitude20230—
+7K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+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—
+7K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+8K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+8K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+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—
+8K201611Apex Knee SystemOmnilife Science20210—
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—