Cleared Traditional

AETOS Shoulder System

K230572 · Smith & Nephew, Inc. · Orthopedic
Jun 2023
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K230572 is an FDA 510(k) clearance for the AETOS Shoulder System, 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 June 7, 2023, 98 days after receiving the submission on March 1, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number K230572 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2023
Decision Date June 07, 2023
Days to Decision 98 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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