iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System

iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is an FDA 510(k)-cleared medical device (K243768) manufactured by Restor3D, 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 26, 2025. Regulation: 8.