# K994393: Aequalis Universal Shoulder Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Jun 22, 2000 after 177 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.
81 later devices descend from it; 3 cite it directly.
0 of 82 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
- K042021: Exactech Equinoxe Shoulder System (2004), 71 descendants of its own
- K093430: Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid Contd. (2010), 24 descendants of its own
- K103419: Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM (2010), 22 descendants of its own
- K111379: Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large / Extra-Large, Left / Right (2011), 21 descendants of its own
- K121220: Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right (2012), 20 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.

Source page: https://510kreport.com/device/K994393
Methodology: https://510kreport.com/methodology