Cleared Traditional

AETOS Shoulder System Meta Humeral Prosthesis Size 0

K252416 · Smith & Nephew, Inc. · Orthopedic
Oct 2025
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K252416 is an FDA 510(k) clearance for the AETOS Shoulder System Meta Humeral Prosthesis Size 0, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on October 29, 2025, 89 days after receiving the submission on August 1, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number K252416 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2025
Decision Date October 29, 2025
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3660

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