Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®

Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® is an FDA 510(k)-cleared medical device (K230416) manufactured by Stryker. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 18, 2023. Regulation: 8.