510(k) Report

Devices descending from K030301

30 later devices reach Unicondylar Femoral Component 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
+1K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120—
+1K073175Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.200726—
+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—
+2K183029MOTO Partial Knee SystemMedacta International S.A.20192—
+2K161741GMK UniMedacta International S.A.20172—
+2K162084MOTO Partial Knee SystemMedacta International S.A.20173—
+2K152315JOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.20158—
+2K100197Genesis Unicondylar Uhmwpe Articular InsertsSmith & Nephew, Inc.20100—
+2K081351Modification to Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.200818—
+3K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—
+3K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.20211—
+3K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+3K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+3K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+3K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+4K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+4K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+4K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+4K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+4K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+5K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+5K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+6K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—