EVOLUTION® Hinge Knee System

EVOLUTION® Hinge Knee System is an FDA 510(k)-cleared medical device (K230563) manufactured by Microport Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 26, 2023. Regulation: 8.