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hemicap humeral head xl hhxl articular resurfacing system
Arthrosurface
Summary: The HemiCAP Humeral Head XL HHXL Articular Resurfacing System is a medical device used for shoulder joint resurfacing. It is typically used by orthopedic surgeons to treat patients with shoulder joint damage.
FDA Clearance Information
Pathway
510K
Number
K142942 ↗
Decision Date
December 19, 2014
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The HemiCAP Humeral Head XL HHXL was cleared through the FDA 510(k) pathway on December 19, 2014. It is manufactured by Arthrosurface and classified as a Class 2 device under product code HSD.
What It Is
The HemiCAP Humeral Head XL HHXL is a joint resurfacing system designed to treat articular cartilage damage in the shoulder. It involves a contoured implant that fits the patient's anatomy, providing a smooth surface to restore joint function. This device is particularly useful for patients who have focal cartilage lesions, offering an alternative to total joint replacement.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly in cases of shoulder joint damage due to osteoarthritis or post-traumatic cartilage lesions. It is suitable for patients who are not candidates for total shoulder arthroplasty, such as younger patients or those with localized cartilage damage. The device is typically used in hospital or outpatient surgical settings.
Indications for Use
The HemiCAP Humeral Head XL HHXL is indicated for patients with shoulder joint damage, particularly those with focal cartilage lesions or early-stage osteoarthritis. It is designed to relieve pain and restore function in patients who are not yet candidates for total shoulder replacement.
Practical Considerations
The device comes in various sizes to accommodate different patient anatomies. Surgeons should ensure proper sizing and alignment during implantation to optimize outcomes. Compatibility with existing surgical instruments and techniques is generally straightforward, but familiarity with the system is recommended.
Frequently Asked Questions
What is HemiCAP Humeral Head XL HHXL used for?
It is used for resurfacing the shoulder joint in patients with cartilage damage, providing pain relief and improved function.
What specialties typically use this device?
Orthopedic surgeons specializing in shoulder surgery typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with shoulder joint damage, particularly those with focal cartilage lesions or early-stage osteoarthritis.
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.