đź“‹ FDA Reference
Interlok Ha Copeland Resurfacing Heads
Biomet
Summary: The Interlok HA Copeland Resurfacing Heads are orthopedic devices used in joint resurfacing procedures, primarily by orthopedic surgeons. They are designed to treat patients with joint degeneration.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K010635 ↗
Decision Date ?
August 20, 2001
Product Code ?
MBF
Device Class ?
Class 2
Evidence ?
0 studies
The Interlok HA Copeland Resurfacing Heads were cleared through the FDA 510(k) pathway on August 20, 2001. Manufactured by Biomet, this Class 2 device falls under the product code MBF.
What It Is
The Interlok HA Copeland Resurfacing Heads are orthopedic implants used in joint resurfacing procedures. They are designed to replace the surface of a joint, typically in the shoulder, to alleviate pain and restore function in patients with degenerative joint conditions. The device features a hydroxyapatite coating to promote bone integration and stability.
FDA-Cleared Indications
- Joint resurfacing in patients with osteoarthritis.
- Joint resurfacing in patients with post-traumatic arthritis.
- Use in patients with painful joint degeneration and reduced function when conservative treatment has not provided adequate relief.
Clinical Applications
- Shoulder joint resurfacing using a Copeland-type resurfacing head.
- Treatment of painful shoulder joint degeneration associated with osteoarthritis.
- Treatment of post-traumatic arthritis affecting the joint.
- Use in adults whose pain and functional limitation have not responded adequately to nonsurgical treatment.
Practical Considerations
- The resurfacing head is selected in a size and configuration that match the patient's joint anatomy.
- Implantation requires open orthopedic surgery, appropriate instrumentation, and preparation of the joint surface according to the manufacturer's surgical technique.
- The hydroxyapatite coating is intended to support bone attachment, but fixation and clinical outcome depend on bone quality, implant positioning, and postoperative care.
- The FDA record does not establish MRI safety for every implant configuration; MRI conditions should be confirmed from the current device labeling and implant documentation before scanning.
- Contraindications and precautions include infection, inadequate bone stock, severe bone loss, and other conditions identified in the manufacturer's labeling.
Frequently Asked Questions
What is Interlok HA Copeland Resurfacing Heads used for?
They are used for joint resurfacing in patients with degenerative joint conditions to relieve pain and improve function.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and reconstruction commonly use this device.
What are the FDA-cleared indications?
The device is indicated for joint resurfacing in patients with osteoarthritis or post-traumatic arthritis 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.