ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) is an FDA 510(k)-cleared medical device (K161668) 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 14, 2016. Regulation: 8.