Episealer Patellofemoral System

Episealer Patellofemoral System is an FDA 510(k)-cleared medical device (K221048) manufactured by Episurf Medical, 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 December 22, 2022. Regulation: 8.