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FDA 510(k)

AETOS Shoulder System - CONCELOC Glenoids

K-Number: K254084 · 2026-04-06

ApplicantSmith & Nephew, Inc.
Decision Date2026-04-06
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AETOS Shoulder System - CONCELOC Glenoids is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2026-04-06 under approval 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. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K254084.

When was AETOS Shoulder System - CONCELOC Glenoids approved by the FDA?

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

What company makes AETOS Shoulder System - CONCELOC Glenoids?

AETOS Shoulder System - CONCELOC Glenoids is manufactured by Smith & Nephew, Inc..

What is the FDA product code for AETOS Shoulder System - CONCELOC Glenoids?

The FDA product code for AETOS Shoulder System - CONCELOC Glenoids is KWS.

Related Clinical Trials

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

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Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

Official Source

View on FDA Database →

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

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