# K061454: Exactech Equinoxe Shoulder Stems

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Jun 12, 2006 after 18 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: 4 generations back to K911686 (1991). 28 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042021: Exactech Equinoxe Shoulder System, Exactech, Inc. (2004) Summary page 2.

## Most influential descendants
- K093599: Arrow Anatomical Shoulder System (2010), 11 descendants of its own
- K112193: Arrow Reverse Shoulder System (2012), 10 descendants of its own
- K142778: ARROW Reverse Shoulder long keel and short keel glenoid base (2015), 5 descendants of its own
- K162068: ARROW Anatomical Porous glenoid (2017), 4 descendants of its own
- K150568: ARROW Humeral stems size 6 and 16 (2015), 4 descendants of its own

## Indications for use
The Equinoxe TM Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment. Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows: rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems congenital abnormalities in the skeletally mature primary and secondary necrosis of the humeral head. humeral head fracture with displacement of the tuberosities pathologies where arthodesis or resectional arthroplasty of the humeral head are not acceptable revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved) displaced three-part and four-part upper humeral fractures spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) revision of failed previous reconstructions when distal anchorage is required to restore mobility from previous procedures (e.g. previous fusion)

Source page: https://510kreport.com/device/K061454
Methodology: https://510kreport.com/methodology