# K252788: Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Jan 8, 2026 after 128 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K911686 (1991). 119 ancestors in all.
No later device cites it as a predicate yet.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid, Tornier, Inc. (2016) Summary page 5.
- K211359: Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation, Tornier, Inc. (2021) Summary page 5.
- K061439: Aequalis Reversed Prosthesis, Tornier (2006) Summary page 5.
- K173900: Arthrex Univers Revers Modular Glenoid System, Arthrex, Inc. (2018) Summary page 5.

## Indications for use
The Tornier PerformTM Reversed MonoPost Glenoid implant is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fractures of the humeral head * Traumatic arthritis * Revision of glenohumeral joint if native glenoid bone remains All components are single use. The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation

Source page: https://510kreport.com/device/K252788
Methodology: https://510kreport.com/methodology