ATLAS™ Expandable Osteotomy Wedge System

ATLAS™ Expandable Osteotomy Wedge System is an FDA 510(k)-cleared medical device (K252733) manufactured by MiRus, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 18, 2026. Regulation: 8.