đź“‹ FDA Reference

cormet 2000 hemi hip metallic resurfacing prosthesis

Corin U

Summary: The Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis is a hip resurfacing device used in orthopedic procedures to treat hip joint issues. It is typically used by orthopedic surgeons for patients requiring hip joint resurfacing.

FDA Clearance Information

Pathway 510K
Decision Date February 25, 2000
Product Code KXA
Device Class Class 2
Evidence 0 studies

The Cormet 2000 was cleared through the FDA 510(k) pathway on February 25, 2000. Manufactured by Corin U, it is classified as a Class 2 device under product code KXA.

What It Is

The Cormet 2000 is a metallic resurfacing prosthesis designed for hemiarthroplasty of the hip. It provides an alternative to total hip replacement by preserving more of the patient's natural bone structure. The device consists of a metal cap that covers the femoral head, helping to restore joint function and alleviate pain.

Clinical Applications

This device is commonly used in orthopedic surgery, particularly for younger, active patients with hip joint degeneration who may benefit from bone-preserving procedures. It is typically utilized in hospital operating rooms by orthopedic surgeons. The Cormet 2000 is suitable for patients with conditions such as osteoarthritis or avascular necrosis affecting the hip joint.

Indications for Use

The Cormet 2000 is indicated for patients who require hip resurfacing due to conditions like osteoarthritis or other degenerative joint diseases. It is particularly beneficial for those who are younger and more active, as it allows for greater preservation of bone.

Practical Considerations

The Cormet 2000 comes in various sizes to accommodate different patient anatomies. It is important for clinicians to ensure proper sizing and alignment during implantation to optimize outcomes. The device is compatible with standard surgical instruments used in hip resurfacing procedures.

Frequently Asked Questions

What is the Cormet 2000 used for?

The Cormet 2000 is used for hip resurfacing in patients with degenerative joint diseases, such as osteoarthritis.

What specialties typically use this device?

Orthopedic surgeons typically use this device in hip resurfacing procedures.

What are the FDA-cleared indications?

The device is indicated for patients needing hip resurfacing due to conditions like osteoarthritis, particularly in younger, active individuals.

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.

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