510(k) Report

Devices descending from K180612

3 later devices reach Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+1K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+2K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—