# K112615: Aequalis Ascend Modular Reverse Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Oct 11, 2011 after 33 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.
97 later devices descend from it; 1 cites it directly.
1 of 193 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110599: Aequalis Ascend Modular Reverse Shoulder System, Tornier, Inc. (2011) Summary page 5.

## Most influential descendants
- K122698: Aequalis Ascend Flex Shoulder System (2013), 96 descendants of its own
- K140082: Aequalis (TM) Ascent (TM) Flex Shoulder System (2014), 29 descendants of its own
- K132285: Aequalis Reversed Shoulder Prosthesis (2013), 26 descendants of its own
- K163669: Humeris Shoulder (2017), 20 descendants of its own
- K151293: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis (2015), 20 descendants of its own

## Indications for use
The Aequalis Ascend Modular Reverse Shoulder System 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 the devices if sufficient bone stock remains The Reverse Metaphysis and Assembly Screw or the Reverse Metaphysis, Reverse Spacer, and Reverse Spacer Assembly Screw are indicated for use as components of the Aequalis Ascend Modular Reverse total shoulder replacement and for transformation of the Aequalis Ascend Anatomic shoulder into a reverse shoulder prosthesis without the removal of the Diaphyseal stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if: The Diaphyseal stem is well fixed The patient has a functional deltoid muscle The arthropathy is associated with a massive and non-repairable rotator cuff-tear. All components are single use The humeral stem is intended for cemented or cementless use The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

Source page: https://510kreport.com/device/K112615
Methodology: https://510kreport.com/methodology