510(k) Report

Devices descending from K094017

7 later devices reach Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101994Apex Knee Modular Tibia SystemOmnlife Science201061
+2K131472Apex Knee Modular Tibia SystemOmni Life Science, Inc.20135—
+3K153437Apex Revision Knee SystemOmnilife Science201541
+4K163332Apex Revision Knee SystemOmnilife Science20173—
+5K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+6K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+6K201611Apex Knee SystemOmnilife Science20210—