Cleared Traditional

AETOS Shoulder System Stemless Humeral Prosthesis

K252129 · Smith & Nephew, Inc. · Orthopedic

Oct 2025

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K252129 is an FDA 510(k) clearance for the AETOS Shoulder System Stemless Humeral Prosthesis, a Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (Class II — Special Controls, product code PKC), submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on October 3, 2025, 88 days after receiving the submission on July 7, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K252129 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2025
Decision Date	October 03, 2025
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty