AFFINITY Proximal Tibia System

AFFINITY Proximal Tibia System is an FDA 510(k)-cleared medical device (K220199) manufactured by Techfit Digital Surgery, 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 20, 2022. Regulation: 8.