# K250713: Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Dec 1, 2025 after 266 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K800494 (1980). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143659: Equinoxe Mega Prosthesis, Exactech, Inc. (2015) Summary page 6.
- K162903: Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies, Exactech, Inc. (2017) Summary page 6.
- K173388: Exactech Equinoxe Stemless Shoulder, Exactech, Inc. (2018) Summary page 6.
- K192097: Exactech® Equinoxe® Stemless Humeral Components, Exactech, Inc. (2020) Summary page 6.

## Indications for use
Humeral Reconstruction Prosthesis The Equinoxe® Humeral Reconstruction Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of: • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis • Rheumatoid arthritis • Revision where other devices or treatments have failed • Correction of functional deformity • Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment • Traumatic arthritis • Oncology applications including bone loss due to tumor resection. • Significant humeral resection which are unmanageable using other treatment methods The Equinoxe® Humeral Reconstruction Prosthesis System can be used in either primary or revision arthroplasty procedures. The Equinoxe® Humeral Reconstruction Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreplaceable and grossly deficient, and a functional deltoid muscle is present. In the USA, the Equinoxe® Humeral Reconstruction Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications. The Equinoxe® Humeral Reconstruction Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe® Humeral Reconstruction Prosthesis Distal Stem Collars are only for uncemented, press-fit use. Stemless Shoulder 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/K250713
Methodology: https://510kreport.com/methodology