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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
510K
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.
Clinical Applications
These resurfacing heads are commonly used in orthopedic surgeries to treat patients with osteoarthritis or other degenerative joint diseases. They are typically used in settings such as hospitals or specialized orthopedic clinics. The primary patient population includes adults suffering from joint pain and reduced mobility due to cartilage wear.
Indications for Use
The FDA-cleared indications for this device include use in patients requiring joint resurfacing due to conditions like osteoarthritis or post-traumatic arthritis. It is intended for those who have not responded to conservative treatments.
Practical Considerations
The Interlok HA Copeland Resurfacing Heads come in various sizes to accommodate different joint anatomies. They are compatible with other Biomet implant systems, and proper surgical technique is crucial for optimal outcomes. Surgeons should be familiar with the device's specific instrumentation and placement techniques.
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.