FDA 510(k)

AETOS Shoulder System Meta Humeral Prosthesis Size 0

K-Number: K252416 · 2025-10-29

Decision Date2025-10-29

Product CodeKWS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AETOS Shoulder System Meta Humeral Prosthesis Size 0 is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K252416. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AETOS Shoulder System Meta Humeral Prosthesis Size 0?

AETOS Shoulder System Meta Humeral Prosthesis Size 0 is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K252416.

When did AETOS Shoulder System Meta Humeral Prosthesis Size 0 receive FDA 510(k) clearance?

AETOS Shoulder System Meta Humeral Prosthesis Size 0 received FDA 510(k) clearance on 2025-10-29, under 510(k) number K252416.

Who is the listed applicant for AETOS Shoulder System Meta Humeral Prosthesis Size 0?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AETOS Shoulder System Meta Humeral Prosthesis Size 0?

The FDA product code for AETOS Shoulder System Meta Humeral Prosthesis Size 0 is KWS.

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Other records listing Smith & Nephew, Inc. as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)K243608TRIGEN Stable Lock Nut & Washer

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Related Devices (Code: KWS)

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.