Freedom Infinia™ Total Knee System

Freedom Infinia™ Total Knee System is an FDA 510(k)-cleared medical device (K253314) manufactured by Maxx Orthopedics, 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 28, 2025. Regulation: 8.