# K183696: Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Jan 30, 2019 after 30 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K911686 (1991). 28 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 33 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 4.

## Most influential descendants
- K210790: Lateralized and Augmented Baseplates (2021), 1 descendant of its own
- K260102: Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System (2026), 0 descendants of its own
- K240278: Full Wedge Lateralized and Augmented Baseplates (2024), 0 descendants of its own
- K203694: DELTA XTEND Reverse Shoulder System (2021), 0 descendants of its own

## Recalls of this device
- Jan 3, 2024 · Class II · Z-0773-2024: The incorrect device is contained in the labeled package.

## Indications for use
The Aequalis™ PerFORM™ Reversed & Aequalis™ PerFORM™+ Reversed Glenoid are 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.

Source page: https://510kreport.com/device/K183696
Methodology: https://510kreport.com/methodology