# K082702: Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter Tray

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Oct 10, 2008 after 24 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.
4 later devices descend from it; 2 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)
- K063569: Equinoxe Reverse Shoulder System, Exactech, Inc. (2007) Summary page 4.

## Most influential descendants
- K223833: Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (2023), 2 descendants of its own
- K260583: Equinoxe® Shoulder System (2026), 0 descendants of its own
- K243448: Equinoxe® Shoulder System (2025), 0 descendants of its own
- K191561: Exactech Equinoxe Humeral Augmented Trays (2019), 0 descendants of its own

## Indications for use
The Exactech® Equinoxe® Reverse Shoulder System is indicated to relieve pain and restore function 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 failed glenochumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

Source page: https://510kreport.com/device/K082702
Methodology: https://510kreport.com/methodology