iTotal® Identity Posterior Stabilized Knee Replacement System

iTotal® Identity Posterior Stabilized Knee Replacement System is an FDA 510(k)-cleared medical device (K201023) manufactured by Conformis, 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 June 15, 2020. Regulation: 8.