510(k) K222317

Catalyst EA Convertible Stemmed Shoulder by Catalyst Orthoscience, Inc. — Product Code KWS

K222317 is an FDA 510(k) premarket notification submitted by Catalyst Orthoscience, Inc. for the device "Catalyst EA Convertible Stemmed Shoulder". The FDA issued a decision of Substantially Equivalent on November 10, 2022. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Catalyst Orthoscience, Inc. has at least 10 other 510(k) clearances on record.