510(k) Report

Devices descending from K912735

52 later devices reach Genesis Unicompartmental Knee System 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
+1K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+1K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120—
+1K102069Journey Unicondylar Tibial BaseplatesSmith & Nephew, Inc.201043—
+1K101206TGS Unicompartmental Knee Arthroplasty (TGS Uka) Modular Tibia SystemAlexandria Research Technologies, LLC20100—
+1K100197Genesis Unicondylar Uhmwpe Articular InsertsSmith & Nephew, Inc.20100—
+1K073175Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.200726—
+1K061779Competitor Unicondylar All-Poly Tibial BaseplateSmith & Nephew, Inc.20065—
+1K061011Competitor Unicondylar Knee Tibial BaseplateSmith & Nephew, Inc.200611—
+2K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+2K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+2K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+2K190633NanoOrtho NanoKnee® SystemNanoortho, LLC20190—
+2K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+2K183029MOTO Partial Knee SystemMedacta International S.A.20192—
+2K161741GMK UniMedacta International S.A.20172—
+2K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+2K162084MOTO Partial Knee SystemMedacta International S.A.20173—
+2K121974Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc.201227—
+2K081351Modification to Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.200818—
+3K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—
+3K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+3K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+3K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.20211—
+3K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+3K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+3K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+3K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+3K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+3K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+3K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+3K132640Iuni Unicondylar Knee Replacement SystemConformis, Inc.2013253
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+4K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+4K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+6K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+6K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+7K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+7K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+8K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+8K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+8K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+9K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+10K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+10K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301