# K182536: Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Oct 12, 2018 after 28 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K911686 (1991). 62 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180632: Exactech Equinoxe Small Reverse Shoulder System, Exactech, Inc. (2018) Summary page 4.
- 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
- K233482: Equinoxe® Central Screw Baseplate System (2024), 0 descendants of its own

## Recalls of this device
- Mar 6, 2024 · Class II · Z-1420-2024: The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain
- Mar 6, 2024 · Class II · Z-1421-2024: The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain
- Nov 21, 2023 · Class II · Z-0579-2024: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

## 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/K182536
Methodology: https://510kreport.com/methodology