Conformis iTotal Cruciate Retaining (CR) Knee Replacement System

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System is an FDA 510(k)-cleared medical device (K180906) 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 May 15, 2018. Regulation: 8.