# K173388: Exactech Equinoxe Stemless Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Mar 9, 2018 after 130 days
- Product code: PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911686 (1991). 34 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143552: Simpliciti Shoulder System, Tornier, Inc. (2015) Summary page 4.
- K042021: Exactech Equinoxe Shoulder System, Exactech, Inc. (2004) Summary page 4.
- K140063: Equinoxe Extra Short Humeral Head, Exactech, Inc. (2014) Summary page 4.

## Most influential descendants
- K182516: Comprehensive Nano Stemless Shoulder (2019), 6 descendants of its own
- K203108: Ignite Stemless Anatomic Shoulder System (2021), 3 descendants of its own
- K241873: OsseoFit Stemless Shoulder System (2024), 1 descendant of its own
- K192097: Exactech® Equinoxe® Stemless Humeral Components (2020), 1 descendant of its own
- K262955: OsseoFit Stemless Shoulder System (2026), 0 descendants of its own

## Indications for use
The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. Clinical indications for anatomic total shoulder arthroplasty are as follows: • Osteoarthritis, osteonecrosis or post-traumatic degenerative problems • Congenital abnormalities in the skeletally mature • Primary and secondary necrosis of the humeral head. • 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 fixation can be achieved) • To restore mobility from previous procedures (e.g. previous fusion) The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use. The Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.

Source page: https://510kreport.com/device/K173388
Methodology: https://510kreport.com/methodology