# K012212: Modification to Aequalis Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Tornier
- Decided: Aug 15, 2001 after 30 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.
246 later devices descend from it; 6 cite it directly.
0 of 247 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
- 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
- K082120: Aequalis Reversed Fracture Shoulder Prothesis (2008), 164 descendants of its own
- K100142: Aequalis Reversed Shoulder Prosthesis (2010), 147 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 glenchumeral joint; non-union humeral head fracture; displaced 4-part proximal humeral fractures; avascular necrogis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.

Source page: https://510kreport.com/device/K012212
Methodology: https://510kreport.com/methodology