# K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Feb 29, 2008 after 63 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- 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.
177 later devices descend from it; 4 cite it directly.
1 of 218 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063569: Equinoxe Reverse Shoulder System, Exactech, Inc. (2007) Summary page 5.

## Most influential descendants
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K112615: Aequalis Ascend Modular Reverse Shoulder System (2011), 97 descendants of its own
- K122698: Aequalis Ascend Flex Shoulder System (2013), 96 descendants of its own
- K120121: Comprehensive Reverse Shoulder-Mini Baseplate (2012), 69 descendants of its own

## Recalls of this device
- Jun 15, 2012 · Class II · Z-2118-2012: Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion dev

## 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 glenchumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe™ Reverse Shoulder is also indicated for falled glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

Source page: https://510kreport.com/device/K073688
Methodology: https://510kreport.com/methodology