ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM

ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM is an FDA 510(k)-cleared medical device (K142161) 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 November 13, 2014. Regulation: 8.