ConforMIS iTotal Posterior Stabilized Knee Replacement System

ConforMIS iTotal Posterior Stabilized Knee Replacement System is an FDA 510(k)-cleared medical device (K153217) 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 January 6, 2016. Regulation: 8.