# K043077: Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Dec 17, 2004 after 39 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: 3 generations back to K920362 (1993). 9 ancestors in all.
258 later devices descend from it; 6 cite it directly.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications, Tornier (1995) Summary page 1.
- K041339: Aequalis Shoulder System, Tornier (2004) Summary page 1.
- K994392: Aequalis Shoulder Fracture System, Tornier (2000) Summary page 1.
- K003728: Modification to Aequalis Shoulder Fracture System, Tornier (2000) Summary page 1.
- K032679: Aequalis Shoulder Fracture System, Tornier (2003) Summary page 1.
- K002683: WMT Ultra-Fit Modular Shoulder System, Wrightmedicaltechnologyinc (2000) Summary page 1.
- K873679: Select Shoulder System, Intermedics Orthopedics (1987) Summary page 1.

## Most influential descendants
- 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
- K071948: Aequalis Reversed Adapter (2007), 178 descendants of its own
- K082120: Aequalis Reversed Fracture Shoulder Prothesis (2008), 164 descendants of its own

## Indications for use
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. 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. Revision surgery when other treatments or devices have failed.

Source page: https://510kreport.com/device/K043077
Methodology: https://510kreport.com/methodology