510(k) Report

Devices descending from K081351

18 later devices reach Modification to Journey Unicondylar Femoral Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20178—
+1K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+2K203341ACS LD Uni FB Knee SystemImplantcast GmbH20211—
+2K191996BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20193—
+2K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20194—
+2K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+2K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+2K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc.20197—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+3K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+3K212307BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—
+3K203697BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20212—
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K211895BC Reflex Uni Knee SystemBodycad Laboratories, Inc.20210—