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FDA 510(k)

Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads

K-Number: K182799 · 2019-03-08

ApplicantArthrex, Inc.
Decision Date2019-03-08
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-03-08 under approval number K182799. 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 Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads?

Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads is a medical device that received FDA 510(k) clearance on 2019-03-08. It is manufactured by Arthrex, Inc.. The 510(k) number is K182799.

When was Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads approved by the FDA?

Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads received FDA 510(k) clearance on 2019-03-08, under approval number K182799.

What company makes Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads?

Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads?

The FDA product code for Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads is KWS.

Related Clinical Trials

NCT07615465 An Osseointegrated Transfemoral Prosthesis Offering Long-Term Bi-Directional Efferent-Afferent Neural Transmission ACTIVE_NOT_RECRUITING 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

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 Arthrex, Inc.

K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing K161782Arthrex Univers Revers Shoulder Prosthesis System K161581Arthrex Synergy RF System K161108Arthrex VaultLock Glenoid K160319FiberTak DR K151527Arthrex Univers Revers CA Heads and Adapters

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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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