# K063081: Aequalis Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Tornier
- Decided: Nov 9, 2006 after 30 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- 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). 21 ancestors in all.
162 later devices descend from it; 3 cite it directly.
0 of 184 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.
- K043077: Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System, Tornier (2004) Summary page 1.
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System, Tornier (2006) Summary page 1.
- K060874: Depuy Global AP Shoulder System, DePuy Orthopaedics, Inc. (2006) Summary page 1.

## Most influential descendants
- K071147: Nexa Orthopedics Total Shoulder System (2007), 120 descendants of its own
- K102924: Aequalis Ascend Modular Anatomic Shoulder System (2011), 110 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K113413: Ascend Shoulder System (2012), 105 descendants of its own
- K120794: Ascend Shoulder System (2012), 98 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.

Source page: https://510kreport.com/device/K063081
Methodology: https://510kreport.com/methodology