510(k) K254084

AETOS Shoulder System - CONCELOC Glenoids by Smith & Nephew, Inc. — Product Code KWS

K254084 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "AETOS Shoulder System - CONCELOC Glenoids". The FDA issued a decision of Substantially Equivalent on April 6, 2026. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.