510(k) K252418

Catalyst F1x Shoulder System by Catalyst Orthoscience, Inc. — Product Code KWS

K252418 is an FDA 510(k) premarket notification submitted by Catalyst Orthoscience, Inc. for the device "Catalyst F1x Shoulder System". The FDA issued a decision of Substantially Equivalent on November 6, 2025. 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.