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nexgen complete knee solution 9mm articular surface
Zimmer
Summary: The NexGen Complete Knee Solution 9mm Articular Surface by Zimmer is a knee replacement component used in orthopedic surgeries for patients with severe knee joint issues. It is primarily utilized by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K951185 ↗
Decision Date
March 15, 1996
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The NexGen Complete Knee Solution 9mm Articular Surface was cleared through the FDA 510(k) pathway on March 15, 1996. Manufactured by Zimmer, it is classified as a Class 2 device under product code JWH.
What It Is
The NexGen Complete Knee Solution 9mm Articular Surface is a component of a total knee replacement system. It is designed to replace the articular surface of the knee joint, providing a smooth, durable interface for joint movement. Made from biocompatible materials, it is intended to alleviate pain and restore function in patients with degenerative joint disease or severe knee damage.
Clinical Applications
This device is commonly used in total knee arthroplasty procedures, particularly for patients with osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. Orthopedic surgeons in hospital or surgical center settings typically perform these procedures. It is suitable for adult patients who have not responded to conservative treatments and require surgical intervention to improve mobility and reduce pain.
Indications for Use
The FDA indications suggest this device is for patients requiring knee joint replacement due to severe arthritis or significant joint damage. It is intended to restore joint function and relieve pain in individuals who have not benefited from less invasive treatments.
Practical Considerations
The NexGen system offers various sizing options to accommodate different patient anatomies. It is compatible with other components of the NexGen knee system. Surgeons should be familiar with the specific surgical technique associated with this system to ensure optimal outcomes.
Frequently Asked Questions
What is NexGen Complete Knee Solution used for?
It is used in total knee replacement surgeries to replace damaged knee joint surfaces.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement surgeries typically use this device.
What are the FDA-cleared indications?
It is indicated for patients with severe knee arthritis or joint damage requiring knee replacement.
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.