# K102924: Aequalis Ascend Modular Anatomic Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Jan 31, 2011 after 123 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: 8 generations back to K800494 (1980). 56 ancestors in all.
110 later devices descend from it; 3 cite it directly.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071147: Nexa Orthopedics Total Shoulder System, Nexa Orthopedics, Inc. (2007) Summary page 2.
- K980244: Aequalis Shoulder Prosthesis, Tornier (1999) Summary page 2.
- K011942: Aequalis Press-Fit Shoulder Prosthesis, Tornier (2001)
- K063081: Aequalis Shoulder System, Tornier (2006) Summary page 2.
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications, Tornier (1995) Summary page 2.
- K060988: Total and Hemi Shoulder System, Dvo Extremity Solutions, LLC (2006) Summary page 2.
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 2.

## Most influential descendants
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K112615: Aequalis Ascend Modular Reverse Shoulder System (2011), 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

## Indications for use
The Aequalis 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/K102924
Methodology: https://510kreport.com/methodology