# K081707: Aequalis Shoulder Fracture and Shoulder Systems

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Jul 17, 2008 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
Longest line of descent: 5 generations back to K920362 (1993). 23 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994392: Aequalis Shoulder Fracture System, Tornier (2000) Summary page 1.
- K003728: Modification to Aequalis Shoulder Fracture System, Tornier (2000) Summary page 1.
- K012212: Modification to Aequalis Shoulder System, Tornier (2001) Summary page 1.
- K032679: Aequalis Shoulder Fracture System, Tornier (2003) Summary page 1.
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System, Tornier (2006) Summary page 1.
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications, Tornier (1995) Summary page 1.
- K980244: Aequalis Shoulder Prosthesis, Tornier (1999) Summary page 1.
- K041339: Aequalis Shoulder System, Tornier (2004) Summary page 1.
- K043077: Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System, Tornier (2004) Summary page 1.
- K060988: Total and Hemi Shoulder System, Dvo Extremity Solutions, LLC (2006) Summary page 1.

## Most influential descendants
- 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
- K150583: Aequalis PerFORM+ Shoulder System (2015), 16 descendants of its own

## Indications for use
Aequalis Shoulder System (excluding Aequalis Shoulder Fracture System): Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: · Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. · Primary and secondary necrosis of the humeral head * Displaced 4-part upper humeral fracture * Humeral head fracture * Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable : Revision surgery when other treatments or devices have failed. Aequalis Shoulder Fracture System Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including o humeral head fracture and displaced 3-or 4-part proximal humeral fractures. o Revision surgery when other treatments or devices have failed.

Source page: https://510kreport.com/device/K081707
Methodology: https://510kreport.com/methodology