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copeland mb ha resurfacing humeral heads
Biomet Orthopedics
Summary: The Copeland MB HA Resurfacing Humeral Heads is a medical device used for shoulder joint resurfacing, primarily in patients with arthritis or joint degeneration. It is typically used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K010827 ↗
Decision Date
September 14, 2001
Product Code
HSD
Device Class
Class 2
Evidence
0 studies
The Copeland MB HA Resurfacing Humeral Heads was cleared through the FDA 510k pathway on September 14, 2001. Manufactured by Biomet Orthopedics, it is classified as a Class 2 device.
What It Is
The Copeland MB HA Resurfacing Humeral Heads is a prosthetic device designed for the resurfacing of the humeral head in the shoulder joint. It is used to replace damaged joint surfaces, particularly in cases of arthritis or other degenerative joint diseases. The device is made from biocompatible materials and is designed to mimic the natural anatomy of the shoulder, providing pain relief and improved joint function.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly in shoulder arthroplasty procedures. It is suitable for patients with osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the shoulder. The device is typically used in hospital settings by orthopedic surgeons specializing in joint replacement and reconstruction.
Indications for Use
The FDA indications suggest that this device is intended for patients who require shoulder joint resurfacing due to conditions like arthritis or joint degeneration. It is suitable for those who have not responded to conservative treatments.
Practical Considerations
The Copeland MB HA Resurfacing Humeral Heads comes in various sizes to accommodate different patient anatomies. It is important for surgeons to select the appropriate size and ensure proper alignment during implantation to optimize outcomes. Compatibility with existing surgical instruments and techniques is generally straightforward.
Frequently Asked Questions
What is the Copeland MB HA Resurfacing Humeral Heads used for?
It is used for resurfacing the humeral head in the shoulder joint, primarily in patients with arthritis or joint degeneration.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in joint replacement and reconstruction, typically use this device.
What are the FDA-cleared indications?
The device is indicated for shoulder joint resurfacing in patients with arthritis or degenerative joint conditions who have not responded to other treatments.
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.