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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 the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2026-01-08 under 510(k) 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. The listed applicant is Tornier, Inc.. The 510(k) number is K252788.

When did Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) receive FDA 510(k) clearance?

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

Who is the listed applicant for Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)?

The FDA 510(k) record lists Tornier, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07764614Tornier Perform™ Reversed Monopost StudyNOT_YET_RECRUITINGNCT05500066Tornier HRS (Humeral Reconstruction System) Study (REVIVE)ENROLLING_BY_INVITATIONNCT05773352Perform® Humeral System - Fracture Study (PFX)ACTIVE_NOT_RECRUITINGNCT07667647MoDi Twin Placental ImagingNOT_YET_RECRUITING

Other records listing Tornier, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260721Tornier Perform Advanced GlenoidK251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)K230352Tornier Humeral Nail and Tornier Long Humeral NailK220914Tornier Perform Humeral System – FractureK220418Tornier Perform Humeral System – StemlessK211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation

View all 19 devices →

Related Devices (Code: PHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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