# K141029: Tornier Aequalis Adjustable Reverse Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Jun 18, 2014 after 57 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: 13 generations back to K911686 (1991). 96 ancestors in all.
No later device cites it as a predicate yet.
1 of 97 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120739: Aequalis Adjustable Modular Reverse Shoulder System, Tornier, Inc. (2012) Summary page 4.

## Indications for use
The Aequalis Adjustable Reversed Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non repairable rotator cuff tear as a replacement of Shoulder joints disabled by: * Rheumatoid arthritis with pain * 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 humeral stems: * The uncoated humeral stems are for cemented or cementless use; * The titanium plasma spray coated stems are for cemented or cementless use; * The hydroxylapatite coated stems are for cementless use only * The hydroxylapatite over titanium plasma spray coated stems are for cementless use only The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

Source page: https://510kreport.com/device/K141029
Methodology: https://510kreport.com/methodology