# K063569: Equinoxe Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Feb 23, 2007 after 86 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K911686 (1991). 39 ancestors in all.
190 later devices descend from it; 16 cite it directly.
1 of 230 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 1.
- K050315: Delta Humeral Cups, DePuy Orthopaedics, Inc. (2005) Summary page 1.
- K062116: Delta Cta Reverse Shoulder System Humeral Heads, DePuy Orthopaedics, Inc. (2006) Summary page 1.
- K030941: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 1.
- K041873: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 1.
- K050316: Aequalis Reversed Shoulder Prosthesis, Tornier (2005) Summary page 1.
- K052906: Zimmer Trabecular Metal Reverse Shoulder System, Zimmer, Inc. (2005) Summary page 1.
- K060704: Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM, Zimmer, Inc. (2006) Summary page 1.
- K053274: Anatomical Shoulder Inverse/Reverse, Zimmer GmbH (2006) Summary page 1.
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 1.
- K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 1.
- K052086: Encore Reverse Shoulder Prosthesis Humeral Stem Adapter, Encore Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw (2008), 177 descendants of its own
- 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

## Recalls of this device
- Aug 15, 2025 · Class II · Z-2561-2025: Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
- Mar 6, 2024 · Class II · Z-1422-2024: 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-1418-2024: 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-1425-2024: 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-1423-2024: 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-1424-2024: 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-1419-2024: 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.
- Aug 24, 2020 · Class II · Z-3019-2020: Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
- Aug 24, 2020 · Class II · Z-3020-2020: Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
- Aug 21, 2018 · Class II · Z-0012-2019: The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.
- Oct 25, 2016 · Class II · Z-0900-2017: Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
- Jun 15, 2012 · Class II · Z-2117-2012: 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 EquinoxeTM Reverse Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The EquinoxeTM Reverse Shoulder is also indicated for failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

Source page: https://510kreport.com/device/K063569
Methodology: https://510kreport.com/methodology