iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)

iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is an FDA 510(k)-cleared medical device (K210809) 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 11, 2021. Regulation: 8.