# K952928: Aequalis Shoulder System for Total & Hemishoulder Applications

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Sep 27, 1995 after 93 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.
393 later devices descend from it; 19 cite it directly.
1 of 394 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032679: Aequalis Shoulder Fracture System (2003), 287 descendants of its own
- K030941: Aequalis Reversed Shoulder Prosthesis (2004), 280 descendants of its own
- K041873: Aequalis Reversed Shoulder Prosthesis (2004), 277 descendants of its own
- K041339: Aequalis Shoulder System (2004), 259 descendants of its own
- K043077: Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System (2004), 258 descendants of its own

Source page: https://510kreport.com/device/K952928
Methodology: https://510kreport.com/methodology