510(k) Report

Devices descending from K061011

11 later devices reach Competitor Unicondylar Knee Tibial Baseplate 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—
+1K100197Genesis Unicondylar Uhmwpe Articular InsertsSmith & Nephew, Inc.20100—
+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—
+2K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+3K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+3K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+3K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—