# K260102: Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation (Tornier, Inc.)
- Decided: Jun 12, 2026 after 150 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: 11 generations back to K911686 (1991). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 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.
- K183696: Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid, Tornier, Inc. (2019). Our OCR of the scanned summary read K182696, FDA’s number for Telepack X LED (KARL STORZ Endoscopy-America, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aequalis PerFORM Reversed Glenoid and Aequalis PerFORM+ Reversed…”.
- K213124: Tomier Perform™ Reversed Glenoid Cannulated Glenospheres, Tornier, Inc. (2021) Summary page 6.

## Indications for use
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 the devices if sufficient bone stock remains Notes: * All components are single use. * The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation. * All compatible humeral components are available for cemented or non-cemented fixation.

Source page: https://510kreport.com/device/K260102
Methodology: https://510kreport.com/methodology