Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts is an FDA 510(k)-cleared medical device (K180612) manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 6, 2018. Regulation: 8.