# K150458: Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: May 14, 2015 after 80 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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: 9 generations back to K911686 (1991). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063569: Equinoxe Reverse Shoulder System, Exactech, Inc. (2007) Summary page 4.

## Most influential descendants
- K193098: Exactech® Equinoxe® Reverse Shoulder Glenospheres (2020), 0 descendants of its own

## Indications for use
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

Source page: https://510kreport.com/device/K150458
Methodology: https://510kreport.com/methodology