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prolong highly crosslinked polyethtylene cruciate retaining cr articular surface components
Zimmer
Summary: The Prolong Highly Crosslinked Polyethylene CR Articular Surface is a knee replacement component used in orthopedic surgeries. It is designed for patients needing knee joint replacements, typically used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K013991 ↗
Decision Date
December 27, 2001
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on December 27, 2001. Manufactured by Zimmer, it is classified as a Class 2 medical device under product code JWH.
What It Is
The Prolong Highly Crosslinked Polyethylene CR Articular Surface is a component used in knee arthroplasty procedures. It is made from a durable, highly crosslinked polyethylene material, designed to replace the articular surface of the knee joint. This material is known for its wear resistance, which is crucial for the longevity of knee implants.
Clinical Applications
This device is commonly used in total knee arthroplasty (TKA) procedures, particularly in patients with severe knee arthritis or damage. Orthopedic surgeons utilize this component in hospital operating rooms or specialized surgical centers. It is suitable for adult patients who require knee joint replacement due to degenerative joint diseases.
Indications for Use
The device is indicated for use in patients requiring knee replacement surgery, typically due to conditions like osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. It is intended to restore joint function and relieve pain.
Practical Considerations
The Prolong Highly Crosslinked Polyethylene CR Articular Surface is available in various sizes to accommodate different patient anatomies. It is designed to be compatible with cruciate retaining knee systems. Surgeons should ensure proper alignment and fixation during the procedure to optimize outcomes.
Frequently Asked Questions
What is the Prolong Highly Crosslinked Polyethylene CR Articular Surface used for?
It is used in knee replacement surgeries to replace the articular surface of the knee joint.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement surgeries use this device.
What are the FDA-cleared indications?
It is indicated for patients needing knee replacement due to conditions like osteoarthritis or rheumatoid arthritis.
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.