510(k) Report

Devices descending from K951987

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+5K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+5K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K201611Apex Knee SystemOmnilife Science20210—
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+5K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+5K191625Persona Revision Knee SystemZimmer, Inc.201911
+5K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+5K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+5K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+5K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+5K143635KINETIS Total Knee SystemMako Surgical20150—
+5K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+5K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+5K140257Signature Planner, Signature GuidesMaterialise NV20140—
+5K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+5K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+6K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K230078TRAX® CR Total Knee SystemAmplitude20230—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K210551Persona Revision Knee SystemZimmer, Inc.202101
+6K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+6K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+6K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+6K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+6K153437Apex Revision Knee SystemOmnilife Science201541
+6K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—
+6K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+7K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+7K163332Apex Revision Knee SystemOmnilife Science20173—
+7K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+8K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+8K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+8K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+9K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+9K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301