iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System

iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System is an FDA 510(k)-cleared medical device (K230846) 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 July 16, 2023. Regulation: 8.