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orthomet resurfacing femoral component
Orthomet
Summary: The Orthomet Resurfacing Femoral Component is a medical device used in orthopedic procedures to address joint surface issues. It is primarily used by orthopedic surgeons for patients needing joint resurfacing.
FDA Clearance Information
Pathway
510K
Number
K944752 ↗
Decision Date
December 28, 1994
Product Code
KXA
Device Class
Class 2
Evidence
0 studies
The Orthomet Resurfacing Femoral Component was cleared through the FDA 510k pathway on December 28, 1994. Manufactured by Orthomet, it is classified as a Class 2 device under product code KXA.
What It Is
The Orthomet Resurfacing Femoral Component is a prosthetic device designed to replace or resurface the femoral component of a joint, typically the knee or hip. It is used to restore joint function and alleviate pain in patients with damaged joint surfaces. The device is made from biocompatible materials that integrate with the bone, providing a stable and durable joint surface.
Clinical Applications
This device is commonly used in orthopedic surgeries, particularly in joint resurfacing procedures for patients with osteoarthritis or other degenerative joint diseases. It is utilized in both hospital and outpatient surgical settings. The primary patient population includes adults experiencing joint pain and reduced mobility due to worn or damaged cartilage.
Indications for Use
The FDA indications suggest the device is intended for patients with joint surface damage requiring resurfacing. This includes conditions like osteoarthritis where the joint cartilage is worn down, leading to pain and impaired function.
Practical Considerations
Clinicians should consider the sizing and compatibility of the device with the patient's anatomy. Proper surgical technique is crucial for optimal outcomes, and the device should be used in conjunction with compatible surgical instruments and components.
Frequently Asked Questions
What is the Orthomet Resurfacing Femoral Component used for?
It is used for resurfacing the femoral component of a joint to restore function and alleviate pain in patients with damaged joint surfaces.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in joint resurfacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients with joint surface damage requiring resurfacing, such as those with osteoarthritis.
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.