mBôs (Monogram mBôs TKA System)

mBôs (Monogram mBôs TKA System) is an FDA 510(k)-cleared medical device (K242121) manufactured by Monogram Orthopaedics, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 13, 2025. Regulation: 8.