AETOS Shoulder System Stemless Humeral Prosthesis

AETOS Shoulder System Stemless Humeral Prosthesis is an FDA 510(k)-cleared medical device (K252129) manufactured by Smith & Nephew, 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 2, 2025. Regulation: 8.