Restoris Multi-Compartmental Knee System

Restoris Multi-Compartmental Knee System is an FDA 510(k)-cleared medical device (K220930) manufactured by Mako Surgical Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 1, 2022. Regulation: 8.