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FDA 510(k)

AETOS Shoulder System Stemless Humeral Prosthesis

K-Number: K252129 · 2025-10-03

ApplicantSmith & Nephew, Inc.
Decision Date2025-10-03
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AETOS Shoulder System Stemless Humeral Prosthesis is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2025-10-03 under approval number K252129. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AETOS Shoulder System Stemless Humeral Prosthesis?

AETOS Shoulder System Stemless Humeral Prosthesis is a medical device that received FDA 510(k) clearance on 2025-10-03. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K252129.

When was AETOS Shoulder System Stemless Humeral Prosthesis approved by the FDA?

AETOS Shoulder System Stemless Humeral Prosthesis received FDA 510(k) clearance on 2025-10-03, under approval number K252129.

What company makes AETOS Shoulder System Stemless Humeral Prosthesis?

AETOS Shoulder System Stemless Humeral Prosthesis is manufactured by Smith & Nephew, Inc..

What is the FDA product code for AETOS Shoulder System Stemless Humeral Prosthesis?

The FDA product code for AETOS Shoulder System Stemless Humeral Prosthesis is PKC.

Related Clinical Trials

NCT05019664 Affixus Natural Nail System Humeral Nail PMCF ACTIVE_NOT_RECRUITING NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT05505513 Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback? RECRUITING NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT06323980 INHANCE Stemless Reverse Shoulder IDE RECRUITING

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) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

Other Devices by Smith & Nephew, Inc.

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Related Devices (Code: PKC)

K171858Sidus Stem-Free ShoulderZimmer GmbH K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.

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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