510(k) Report

Devices descending from K032215

6 later devices reach VKS/TC-Plus Revision Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053390Columbus (CR) Total Knee SystemAesculap, Inc.200651
+2K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+2K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K201611Apex Knee SystemOmnilife Science20210—