iTotal Posterior Stabilized (PS) Knee Replacement System

iTotal Posterior Stabilized (PS) Knee Replacement System is an FDA 510(k)-cleared medical device (K142404) 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 December 10, 2014. Regulation: 8.