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FDA 510(k)

Aequalis PerFORM+ Shoulder System

K-Number: K160975 · 2016-06-10

ApplicantTornier, Inc.
Decision Date2016-06-10
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aequalis PerFORM+ Shoulder System is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2016-06-10 under approval number K160975. 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 Aequalis PerFORM+ Shoulder System?

Aequalis PerFORM+ Shoulder System is a medical device that received FDA 510(k) clearance on 2016-06-10. It is manufactured by Tornier, Inc.. The 510(k) number is K160975.

When was Aequalis PerFORM+ Shoulder System approved by the FDA?

Aequalis PerFORM+ Shoulder System received FDA 510(k) clearance on 2016-06-10, under approval number K160975.

What company makes Aequalis PerFORM+ Shoulder System?

Aequalis PerFORM+ Shoulder System is manufactured by Tornier, Inc..

What is the FDA product code for Aequalis PerFORM+ Shoulder System?

The FDA product code for Aequalis PerFORM+ Shoulder System is KWS.

Related Clinical Trials

NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT07603609 Sensorimotor Training With a Mobilized Balance Platform in Patients With Chronic Low Back Pain RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT07596550 Comparative Study of Augmented Reality and Virtual Reality in Music Therapy Interventions for Individuals With Cerebral Palsy NOT_YET_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: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Other Devices by Tornier, Inc.

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid K171010Latitude EV Total Elbow Arthroplasty K182461LATITUDE EV Total Elbow Arthroplasty K181587ORTHOLOC SPS Shoulder Plating System K181420Aequalis Flex Revive Shoulder System K191711ORTHOLOC™ SPS Shoulder Plating System

View all 18 devices →

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. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K153602Materialise Glenoid Positioning SystemMaterialise NV

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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