510(k) Report

Devices descending from K191765

2 later devices reach OMNI TiN Coated Apex Knee™ System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+1K201611Apex Knee SystemOmnilife Science20210—