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FDA 510(k)

Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)

K-Number: K252788 · 2026-01-08

ApplicantTornier, Inc.
Decision Date2026-01-08
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2026-01-08 under approval number K252788. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)?

Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) is a medical device that received FDA 510(k) clearance on 2026-01-08. It is manufactured by Tornier, Inc.. The 510(k) number is K252788.

When was Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) approved by the FDA?

Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) received FDA 510(k) clearance on 2026-01-08, under approval number K252788.

What company makes Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)?

Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) is manufactured by Tornier, Inc..

What is the FDA product code for Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)?

The FDA product code for Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) is PHX.

Related Clinical Trials

NCT05500066 Tornier HRS (Humeral Reconstruction System) Study (REVIVE) ENROLLING_BY_INVITATION

Other Devices by Tornier, Inc.

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid K160975Aequalis PerFORM+ Shoulder System K171010Latitude EV Total Elbow Arthroplasty K182461LATITUDE EV Total Elbow Arthroplasty K181587ORTHOLOC SPS Shoulder Plating System K181420Aequalis Flex Revive Shoulder System

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.

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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