# K062661: Aequalis Resurfacing Head

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Dec 22, 2006 after 106 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: 6 generations back to K800494 (1980). 22 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 39 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.
- K012212: Modification to Aequalis Shoulder System, Tornier (2001) 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.
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System, Tornier (2006) 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.
- K010827: Copeland MB/HA Resurfacing Humeral Heads, Biomet Orthopedics, Inc. (2001) Summary page 1.
- K033516: Depuy Global Cap HA Resurfacing Shoulder Humeral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 1.

## Most influential descendants
- K131298: Exactech Equinoxe Resurfacing Humeral Head System (2013), 8 descendants of its own
- K152825: Catalyst CSR Shoulder System (2016), 7 descendants of its own
- K131231: Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prothesis (2013), 5 descendants of its own
- K181287: Catalyst CSR Shoulder System (2018), 3 descendants of its own
- K220914: Tornier Perform Humeral System – Fracture (2022), 2 descendants of its own

## Indications for use
The Aequalis Resurfacing Head is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. The replacement of the joint with this device is indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis. Primary and secondary necrosis of the humeral head. - Humeral head fracture. The Aequalis Resurfacing Head is intended for uncemented use only.

Source page: https://510kreport.com/device/K062661
Methodology: https://510kreport.com/methodology