# K180632: Exactech Equinoxe Small Reverse Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Jul 25, 2018 after 135 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: 12 generations back to K911686 (1991). 61 ancestors in all.
5 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)
- 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.
- K093275: Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral Liner, Exactech, Inc. (2010) Summary page 4.
- K102951: Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short (44MM,47MM), Glenosphere (38MM,42MM), Exactech, Inc. (2010) Summary page 4.
- K131575: Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left & Right, Exactech, Inc. (2013) Summary page 4.

## Most influential descendants
- 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 (2018), 4 descendants of its own
- 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/K180632
Methodology: https://510kreport.com/methodology