# K041339: Aequalis Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Tornier
- Decided: Jun 17, 2004 after 28 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: 1 generation back to K952928 (1995). 2 ancestors in all.
259 later devices descend from it; 7 cite it directly.
0 of 262 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.
- K962315: Select Shoulder Cocr Humeral Stem Component, Intermedics Orthopedics (1996) Summary page 1.

## Most influential descendants
- K043077: Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System (2004), 258 descendants of its own
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System (2006), 257 descendants of its own
- K061439: Aequalis Reversed Prosthesis (2006), 199 descendants of its own
- K081059: Aequalis Reversed Shoulder Prosthesis (2008), 179 descendants of its own
- K071948: Aequalis Reversed Adapter (2007), 178 descendants of its own

## Indications for use
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; non-union humeral head fracture; displaced 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable. The AEQUALIS Shoulder System is intended for cemented use only.

Source page: https://510kreport.com/device/K041339
Methodology: https://510kreport.com/methodology