đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Resurfacing of the humeral head in patients with a damaged shoulder joint.
- Use in shoulder arthroplasty when the humeral head requires replacement or resurfacing.
- Treatment of selected shoulder joint conditions in which preservation of the humeral bone is appropriate.
Clinical Applications
- Humeral head resurfacing arthroplasty for selected patients with shoulder joint disease.
- Treatment of painful or damaged shoulder joints when the humeral head surface can be replaced while retaining much of the underlying bone.
- Use during shoulder reconstruction when a humeral head resurfacing component is selected instead of a stemmed humeral component.
Practical Considerations
- The surgeon selects the component size and position based on the patient’s anatomy, bone quality and condition of the shoulder joint.
- Adequate remaining humeral bone is important for fixation and support; severe bone loss may require another type of shoulder reconstruction.
- The device is used with the compatible instruments and surgical technique specified in the manufacturer’s labeling.
- MRI safety and conditional-use information should be confirmed in the current device labeling and with the imaging facility before an MRI examination.
- Contraindications and precautions include factors such as infection, inadequate bone stock, or other conditions that could prevent stable fixation; the full FDA-cleared labeling should be reviewed.
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.