# K162325: Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Mar 6, 2017 after 199 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: 11 generations back to K911686 (1991). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 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.
- K110708: Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior Augment Glenoid Plate, 10 Degrees..., Exactech, Inc. (2011) Summary page 4.

## 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/K162325
Methodology: https://510kreport.com/methodology