# K191561: Exactech Equinoxe Humeral Augmented Trays

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Aug 20, 2019 after 68 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: 10 generations back to K911686 (1991). 41 ancestors in all.
No later device cites it as a predicate yet.
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.
- K082702: Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter Tray, Exactech, Inc. (2008) Summary page 4.

## Recalls of this device
- May 11, 2021 · Class II · Z-1977-2021: The HAT trial contains a retaining ring that has shown the potential to disengage during use.

## Indications for use
The Equinoxe Humeral Augmented Tray is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in skeletally mature individuals with an intact medial calcar for whom the rotator cuff is irreparable or grossly deficient, a functional deltoid muscle is present, and proximal humeral bone loss is present in cases of: • 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 arthrodesis or resectional arthroplasty of the humeral head are not acceptable • Revisions of humeral prostheses when other treatments or devices have failed (where adequate humeral stem fixation can be achieved) • Displaced three- and four-part upper humeral fractures • Failed ORIF requiring rTSA with an absent or deficient greater tuberosity • Revision of failed previous reconstructions when distal anchorage is required • Treatment of unplanned proximal bone loss during a revision • To restore mobility from previous procedures (e.g. previous fusion) The Equinoxe Humeral Augmented Tray can be used in either primary or revision arthroplasty procedures.

Source page: https://510kreport.com/device/K191561
Methodology: https://510kreport.com/methodology