510(k) K252129

AETOS Shoulder System Stemless Humeral Prosthesis by Smith & Nephew, Inc. — Product Code PKC

K252129 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "AETOS Shoulder System Stemless Humeral Prosthesis". The FDA issued a decision of Substantially Equivalent on October 3, 2025. The device falls under product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained), a Class II device regulated under 21 CFR 888.3660. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.