EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device

EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is an FDA 510(k)-cleared medical device (K202270) manufactured by K1 Medical, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 2020. Regulation: 8.