ROSA Knee System with UltraSound Imaging Platform (USIP)

ROSA Knee System with UltraSound Imaging Platform (USIP) is an FDA 510(k)-cleared medical device (K252058) manufactured by Balmoral Medical, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 2026. Regulation: 8.