Arcos One-piece Femoral Revision System

Arcos One-piece Femoral Revision System is an FDA 510(k)-cleared medical device (K151603) manufactured by Biomet, 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 October 5, 2015. Regulation: 8.