Paragon 28 APEX 3D Total Ankle Replacement System

Paragon 28 APEX 3D Total Ankle Replacement System is an FDA 510(k)-cleared medical device (K192994) 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 July 9, 2020. Regulation: 8.