# K110865: Aequalis Ascend Modular Anatomic Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Apr 27, 2011 after 29 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 9 generations back to K800494 (1980). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have 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 2.

## Indications for use
The Aegualis Ascend Modular Anatomic Shoulder System is indicated for use 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 Notes: All components are single use The humeral stem is intended for cemented or cementless use The glenoid component is intended for cemented use

Source page: https://510kreport.com/device/K110865
Methodology: https://510kreport.com/methodology