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copeland mb resurfacing humeral heads
Biomet Manufacturing
Summary: The Copeland MB Resurfacing Humeral Heads is a medical device used in shoulder joint surgeries, specifically for resurfacing the humeral head. It is typically used by orthopedic surgeons to treat patients with shoulder joint issues.
FDA Clearance Information
Pathway
510K
Number
K010657 ↗
Decision Date
September 14, 2001
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The Copeland MB Resurfacing Humeral Heads was cleared through the FDA 510(k) pathway on September 14, 2001. Manufactured by Biomet Manufacturing, it is classified as a Class 2 device under product code HSD.
What It Is
The Copeland MB Resurfacing Humeral Heads is a prosthetic device designed for shoulder joint surgeries. It is used to resurface the humeral head, which is part of the shoulder joint, providing a smooth surface for articulation. This device is particularly useful in preserving bone stock and is an alternative to total shoulder replacement in certain cases.
Clinical Applications
This device is commonly used in orthopedic settings, particularly in surgeries aimed at treating shoulder arthritis or fractures where joint preservation is preferred. It is suitable for patients who require joint resurfacing rather than a full replacement, making it ideal for younger patients or those with less severe joint damage. The device is typically used in hospital operating rooms or specialized orthopedic centers.
Indications for Use
The FDA indications suggest that this device is for patients needing shoulder joint resurfacing, often due to arthritis or trauma. It is designed for individuals who have sufficient bone stock and do not require a full joint replacement.
Practical Considerations
The Copeland MB Resurfacing Humeral Heads comes in various sizes to accommodate different patient anatomies. It is important for clinicians to ensure proper sizing and alignment during surgery to optimize outcomes. Compatibility with existing surgical instruments and techniques is generally straightforward, but familiarity with the device's specific surgical protocol is recommended.
Frequently Asked Questions
What is Copeland MB Resurfacing Humeral Heads used for?
It is used for resurfacing the humeral head in shoulder joint surgeries, often due to arthritis or trauma.
What specialties typically use this device?
Orthopedic surgeons typically use this device, especially those specializing in shoulder surgeries.
What are the FDA-cleared indications?
The device is indicated for patients needing shoulder joint resurfacing due to conditions like arthritis or trauma, where joint preservation is preferred.
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.