The Optimotion Blue Total Knee System

The Optimotion Blue Total Knee System is an FDA 510(k)-cleared medical device (K191084) manufactured by Optimotion Implants, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 2020. Regulation: 8.