HYALEX® MTP Hemiarthroplasty Implant

HYALEX® MTP Hemiarthroplasty Implant is an FDA 510(k)-cleared medical device (K250074) manufactured by Hyalex Orthopaedics, 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 April 2, 2026. Regulation: 8.