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cormet cementless resurfacing femoral head
Corin U
Summary: The Cormet Cementless Resurfacing Femoral Head is an orthopedic device used in hip resurfacing procedures, primarily by orthopedic surgeons for patients with hip joint degeneration. It offers an alternative to total hip replacement.
FDA Clearance Information
Pathway
510K
Number
K092198 ↗
Decision Date
April 15, 2010
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
The Cormet Cementless Resurfacing Femoral Head was cleared via the FDA 510(k) pathway on April 15, 2010. Manufactured by Corin U, it is classified as a Class 2 device under product code KXA.
What It Is
The Cormet Cementless Resurfacing Femoral Head is a medical device designed for hip resurfacing, a procedure that conserves more of the patient's bone compared to traditional total hip replacement. It involves capping the femoral head with a smooth metal covering, which articulates with a metal acetabular component. This device is particularly beneficial for younger, active patients who may require future revision surgeries.
Clinical Applications
This device is commonly used in orthopedic surgery, specifically in hip resurfacing procedures. It is suitable for patients with osteoarthritis, rheumatoid arthritis, or avascular necrosis of the hip. The typical setting for its use is in hospitals or specialized orthopedic centers, and it is primarily utilized by orthopedic surgeons. The patient population includes younger, active individuals who are likely to benefit from bone-conserving procedures.
Indications for Use
The FDA indications suggest that this device is intended for patients with degenerative joint disease of the hip, such as osteoarthritis or avascular necrosis, who are candidates for hip resurfacing. It is particularly suited for patients who are younger and more active, providing an alternative to total hip replacement.
Practical Considerations
The Cormet Cementless Resurfacing Femoral Head comes in various sizes to accommodate different patient anatomies. It is crucial to ensure proper sizing and alignment during surgery to optimize outcomes. Surgeons should be familiar with the specific surgical technique required for implantation, which differs from traditional hip replacement procedures.
Frequently Asked Questions
What is Cormet Cementless Resurfacing Femoral Head used for?
It is used for hip resurfacing procedures in patients with degenerative hip joint conditions, offering an alternative to total hip replacement.
What specialties typically use this device?
Orthopedic surgeons specializing in hip surgeries and joint preservation techniques typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with degenerative joint disease of the hip, such as osteoarthritis or avascular necrosis, who are candidates for hip resurfacing.
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.