ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM

ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM is an FDA 510(k)-cleared medical device (K133560) 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 March 27, 2014. Regulation: 8.