FDA 510(k)

AETOS Shoulder System - CONCELOC Glenoids

K-Number: K254084 · 2026-04-06

Decision Date2026-04-06

Product CodeKWS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AETOS Shoulder System - CONCELOC Glenoids 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 2026-04-06 under 510(k) number K254084. 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 - CONCELOC Glenoids?

AETOS Shoulder System - CONCELOC Glenoids is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K254084.

When did AETOS Shoulder System - CONCELOC Glenoids receive FDA 510(k) clearance?

AETOS Shoulder System - CONCELOC Glenoids received FDA 510(k) clearance on 2026-04-06, under 510(k) number K254084.

Who is the listed applicant for AETOS Shoulder System - CONCELOC Glenoids?

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 - CONCELOC Glenoids?

The FDA product code for AETOS Shoulder System - CONCELOC Glenoids 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)PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 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.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, 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.