# K994392: Aequalis Shoulder Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Mar 10, 2000 after 73 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
No predicates in its family tree.
290 later devices descend from it; 10 cite it directly.
0 of 291 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K032679: Aequalis Shoulder Fracture System (2003), 287 descendants of its own
- 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

## Indications for use
Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint. Including humeral head fracture and displaced 3 or 4 part proximal humeral fractures.

Source page: https://510kreport.com/device/K994392
Methodology: https://510kreport.com/methodology