Triathlon Total KneeSystem

Triathlon Total KneeSystem is an FDA 510(k)-cleared medical device (K201343) manufactured by Howmedica Osteonics Corp., Dba 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 July 9, 2020. Regulation: 8.