510(k) Report

Devices descending from K070267

12 later devices reach Depuy GCK Tibial Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+1K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC20200—
+1K093056Smith & Nephew, Inc. Journey Select Knee SystemSmith & Nephew, Inc.20099—
+2K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+3K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+3K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—