# K120794: Ascend Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Apr 13, 2012 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). 51 ancestors in all.
98 later devices descend from it; 1 cites it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113413: Ascend Shoulder System, Tornier, Inc. (2012) Summary page 2.
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 2.

## Most influential descendants
- K121493: Ascend Shoulder System (2012), 97 descendants of its own
- 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

## Indications for use
The Ascend Shoulder System consists of a humeral stem, a mating humneral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemniarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Ascend Shoulder System is indicated for use as a replacement of shoulder joints disable by: * Rheumatoid arthritis with pain * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fractures of the humneral head * Traumatic arthritis * Revision of other devices if sufficient bone stock remains All components are single use. The humneral stem is intended for cemented or cementless use, while the all polyethylene glenoid is intended for cemented use only.

Source page: https://510kreport.com/device/K120794
Methodology: https://510kreport.com/methodology