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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
510K
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.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly in cases of shoulder arthritis or other degenerative joint diseases where the humeral head is damaged. It is suitable for patients who require joint resurfacing but wish to avoid the invasiveness of a full stemmed implant. The device is typically used in hospital or surgical center settings by orthopedic specialists.
Indications for Use
The device is indicated for patients with shoulder joint degeneration who need humeral head resurfacing. It is particularly useful for those who have arthritis or other conditions causing joint surface damage.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. Surgeons should consider the patient's bone quality and anatomy when selecting the implant size. Proper placement using anatomical landmarks, such as the anatomic neck, is crucial to avoid complications like joint overstuffing.
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.