# K111902: Aequalis Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Nov 3, 2011 after 121 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: 6 generations back to K920362 (1993). 26 ancestors in all.
49 later devices descend from it; 3 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications, Tornier (1995) Summary page 1.
- K994392: Aequalis Shoulder Fracture System, Tornier (2000) Summary page 1.
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System, Tornier (2006) Summary page 1.
- K063081: Aequalis Shoulder System, Tornier (2006) Summary page 1.
- K060988: Total and Hemi Shoulder System, Dvo Extremity Solutions, LLC (2006) Summary page 1.
- K103007: Affiniti Total and Hemi-Shoulder System, Tornier, Inc. (2010) Summary page 1.

## Most influential descendants
- K143374: BLUEPRINT Patient Specific Instrumentation (2015), 31 descendants of its own
- K160555: BLUEPRINT Patient Specific Instrumentation (2016), 25 descendants of its own
- K162800: BLUEPRINT Patient Specific Instrumentation (2017), 23 descendants of its own
- K203315: BLUEPRINT™ Patient Specific Instrumentation (2021), 18 descendants of its own
- K150583: Aequalis PerFORM+ Shoulder System (2015), 16 descendants of its own

## Indications for use
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary or secondary necrosis of the humeral head - Displaced 4-part upper humeral fracture - Hunieral head fracture Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable. Revision surgery when other treatments or devices have failed. The Aequalis monobloc stein is cemented use. The Aequalis Press-Fit is for uncemented use. Glenoid component is for cemented use..

Source page: https://510kreport.com/device/K111902
Methodology: https://510kreport.com/methodology