Optimotion Implants Porous Metal-Backed Patella

Optimotion Implants Porous Metal-Backed Patella is an FDA 510(k)-cleared medical device (K220049) 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 March 13, 2022. Regulation: 8.