Catalyst R1 Reverse Shoulder System

Catalyst R1 Reverse Shoulder System is an FDA 510(k)-cleared medical device (K223655) manufactured by Catalyst Orthoscience, 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 May 8, 2023. Regulation: 8.