# K042021: Exactech Equinoxe Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Oct 26, 2004 after 90 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K911686 (1991). 27 ancestors in all.
71 later devices descend from it; 14 cite it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980244: Aequalis Shoulder Prosthesis, Tornier (1999) Summary page 2.
- K003801: Anatomical Press-Fit Humeral Stem, Sulzer Orthopedics, Inc. (2001) Summary page 2.
- K032126: Promos Shoulder, Plus Orthopedics (2004) Summary page 2.
- K010124: Arthrex Univers 30 Shoulder Prosthesis, Arthrex, Inc. (2001) Summary page 2.
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 2.
- K994392: Aequalis Shoulder Fracture System, Tornier (2000) Summary page 2.
- K003728: Modification to Aequalis Shoulder Fracture System, Tornier (2000) Summary page 2.
- K032679: Aequalis Shoulder Fracture System, Tornier (2003) Summary page 2.
- K011099: Global FX Porous-Coated Humeral Stem, DePuy Orthopaedics, Inc. (2001). Our reading of the summary gave K101099, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Depuy Global FX fracture humeral stems”. Summary page 2.
- K984541: Global FX Humeral Stem, Global Advantage Humeral Head, DePuy Orthopaedics, Inc. (1999) Summary page 2.
- K974044: Global Total Shoulder Eccentric Humeral Head, DePuy Orthopaedics, Inc. (1998) Summary page 2.
- K001419: Solar Shoulder Offset Humeral Head, Howmedica Osteonics Corp. (2000) Summary page 2.
- K012212: Modification to Aequalis Shoulder System, Tornier (2001) Summary page 2.
- K990137: Anatomica Humeral Stem/Head Components, Sulzer Orthopedics, Inc. (1999) Summary page 2.
- K994393: Aequalis Universal Shoulder Glenoid, Tornier (2000) Summary page 2.
- K960906: Foundation Glenoid Component, Encore Orthopedics, Inc. (1996) Summary page 2.
- K990136: Anatomica Glenoid Component, Sulzer Orthopedics, Inc. (1999) Summary page 2.
- K981487: Depuy Global Shoulder Glenoid, DePuy Orthopaedics, Inc. (1998) Summary page 2.

## Most influential descendants
- K093430: Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid Contd. (2010), 24 descendants of its own
- K103419: Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM (2010), 22 descendants of its own
- K111379: Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large / Extra-Large, Left / Right (2011), 21 descendants of its own
- K121220: Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right (2012), 20 descendants of its own
- K150583: Aequalis PerFORM+ Shoulder System (2015), 16 descendants of its own

## Recalls of this device
- Sep 5, 2025 · Class II · Z-0535-2026: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Sep 5, 2025 · Class II · Z-0537-2026: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Sep 5, 2025 · Class II · Z-0536-2026: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Mar 6, 2024 · Class II · Z-1402-2024: 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-1403-2024: 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-1405-2024: 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-1404-2024: 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 9, 2020 · Class II · Z-0884-2021: Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
- Feb 13, 2015 · Class II · Z-1459-2015: Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
- Jun 15, 2012 · Class II · Z-2115-2012: 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 Equinoxe Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi-arthroplasty is determined by the surgeon to be the preferred method of treatment. Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows: 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 arthodesis or resectional arthroplasty of the humeral head are not acceptable revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved) displaced three-part and four-part upper humeral fractures spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) revision of failed previous reconstructions when distal anchorage is required to restore mobility from previous procedures (e.g. previous fusion)

Source page: https://510kreport.com/device/K042021
Methodology: https://510kreport.com/methodology