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crk condylar resurfacing total knee
Implantology
Summary: The CRK Condylar Resurfacing Total Knee by Implantology is a medical device used in knee replacement surgeries. It is primarily used by orthopedic surgeons to resurface the knee joint in patients with severe arthritis or knee damage.
FDA Clearance Information
Pathway
510K
Number
K915584 ↗
Decision Date
February 12, 1993
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The CRK Condylar Resurfacing Total Knee was cleared by the FDA through the 510(k) pathway on February 12, 1993. It is manufactured by Implantology and classified as a Class 2 device under product code JWH.
What It Is
The CRK Condylar Resurfacing Total Knee is a prosthetic device used in total knee arthroplasty procedures. It is designed to replace the damaged or worn surfaces of the knee joint, providing pain relief and improved mobility for patients with severe joint degeneration. The device typically consists of metal and polyethylene components that mimic the natural movement of the knee.
Clinical Applications
This device is commonly used in orthopedic surgery for patients suffering from osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the knee. It is typically utilized in hospital operating rooms or specialized orthopedic centers. The primary patient population includes older adults with significant knee pain and mobility issues that have not responded to conservative treatments.
Indications for Use
The FDA indications for the CRK Condylar Resurfacing Total Knee include use in patients with severe knee arthritis or damage. It is intended for individuals who require surgical intervention to restore knee function and alleviate pain.
Practical Considerations
The CRK Condylar Resurfacing Total Knee comes in various sizes to accommodate different patient anatomies. Surgeons should ensure compatibility with existing bone structures and consider the patient's activity level when selecting the appropriate component sizes. Proper surgical technique is crucial for optimal outcomes.
Frequently Asked Questions
What is CRK Condylar Resurfacing Total Knee used for?
It is used for total knee replacement surgeries to alleviate pain and restore function in patients with severe knee arthritis or damage.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and reconstructive surgery commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients with severe knee arthritis or damage requiring surgical intervention to restore function and alleviate pain.
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.