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Exactech Equinoxe Resurfacing Humeral Head System
Exactech
Summary: The Exactech Equinoxe Resurfacing Humeral Head System is a medical device used in shoulder arthroplasty to replace the humeral head. It is primarily used by orthopedic surgeons for patients requiring joint resurfacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K131298 ↗
Decision Date ?
November 26, 2013
Product Code ?
HSD
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA's 510(k) pathway on November 26, 2013. It is manufactured by Exactech and classified as a Class 2 device under product code HSD.
What It Is
The Exactech Equinoxe Resurfacing Humeral Head System is designed to replace the surface of the humeral head in shoulder arthroplasty procedures. It provides an anatomic alternative to stemmed implants, aiming to preserve more of the patient's bone structure. The system is intended to mimic the natural anatomy of the shoulder, potentially reducing complications such as joint overstuffing.
FDA-Cleared Indications
- Humeral head resurfacing during shoulder arthroplasty for patients with a damaged or diseased shoulder joint.
- Use in patients whose humeral head anatomy and bone quality are suitable for a resurfacing implant.
- Treatment of shoulder joint conditions requiring replacement of the humeral head articular surface, as specified in the device labeling.
Clinical Applications
- Humeral head resurfacing for shoulder arthritis and degenerative joint disease.
- Replacement of the damaged articular surface of the humeral head during shoulder arthroplasty.
- Use as an anatomic alternative to a stemmed humeral shoulder implant when the patient’s bone stock and anatomy are appropriate.
- Implant selection in various sizes to match the patient’s humeral head anatomy.
Practical Considerations
- The system is available in multiple sizes; the surgeon must match the implant to the patient’s anatomy and available bone stock.
- Adequate humeral bone quality and proper preparation of the humeral head are important for implant stability.
- Correct positioning relative to the anatomic neck and native shoulder anatomy helps reduce malposition and joint overstuffing.
- MRI safety and MRI conditions depend on the complete implanted construct and the manufacturer’s current labeling; patients should provide the implant information before an MRI.
- Contraindications and precautions include infection, inadequate bone stock, severe bone loss, or other conditions that prevent reliable fixation; the current instructions for use should be reviewed.
Related Literature
The linked study assessed the use of the anatomic neck as a landmark for placing humeral head resurfacing implants. It found that while resurfacing can be more anatomic than stemmed implants, improper placement can lead to joint overstuffing. The study highlights the importance of accurate implant positioning but notes that not all resurfacing procedures achieve optimal anatomical reproduction.
Frequently Asked Questions
What is the Exactech Equinoxe Resurfacing Humeral Head System used for?
It is used for shoulder joint resurfacing in patients with degenerative joint diseases such as arthritis.
What specialties typically use this device?
Orthopedic surgeons specializing in shoulder arthroplasty commonly use this device.
What are the FDA-cleared indications?
It is indicated for patients with shoulder joint degeneration requiring humeral head resurfacing, particularly those with arthritis or joint surface damage.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.