APEX 3D Total Ankle Replacement System

APEX 3D Total Ankle Replacement System is an FDA 510(k)-cleared medical device (K240259) manufactured by Paragon 28, 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 June 23, 2024. Regulation: 8.