Tornier Humeral Reconstruction System Max (Tornier HRS Max)

Tornier Humeral Reconstruction System Max (Tornier HRS Max) is an FDA 510(k)-cleared medical device (K251686) manufactured by Tornier, 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 29, 2025. Regulation: 8.