# K120739: Aequalis Adjustable Modular Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Jul 5, 2012 after 115 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: 12 generations back to K911686 (1991). 95 ancestors in all.
12 later devices descend from it; 3 cite it directly.
1 of 108 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102924: Aequalis Ascend Modular Anatomic Shoulder System, Tornier, Inc. (2011) Summary page 5.
- K110599: Aequalis Ascend Modular Reverse Shoulder System, Tornier, Inc. (2011) Summary page 5.
- K081059: Aequalis Reversed Shoulder Prosthesis, Tornier (2008) Summary page 5.
- K100142: Aequalis Reversed Shoulder Prosthesis, Tornier (2010) Summary page 5.
- K082120: Aequalis Reversed Fracture Shoulder Prothesis, Tornier (2008) Summary page 5.

## Most influential descendants
- K130050: Titan Reverse Shoulder System (2013), 9 descendants of its own
- K161189: Integra TITAN Reverse Shoulder System (2016), 8 descendants of its own
- K190588: Integra TITAN Reverse Shoulder System (2019), 4 descendants of its own
- K173717: Integra TITAN Reverse Shoulder System (2018), 3 descendants of its own
- K181999: Integra TITAN Reverse Shoulder System (2018), 2 descendants of its own

## Indications for use
The Aequalis Adjustable Reverse 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 hydroxylapatite 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/K120739
Methodology: https://510kreport.com/methodology