đź“‹ FDA Reference
nexgen compl knee sol legacy posterior stabilized constrained condylar knee femoral components articular surfaces
Zimmer
Summary: The NexGen Complete Knee Solution is a knee replacement system used in orthopedic surgery to address severe knee joint issues. It is primarily used by orthopedic surgeons for patients requiring knee arthroplasty.
FDA Clearance Information
Pathway
510K
Number
K960279 ↗
Decision Date
April 26, 1996
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The NexGen Complete Knee Solution by Zimmer was cleared through the FDA 510(k) pathway on April 26, 1996. It is classified as a Class 2 device under product code JWH.
What It Is
The NexGen Complete Knee Solution is a comprehensive knee replacement system designed to provide stability and mobility for patients with severe knee joint degeneration. It includes femoral components and articular surfaces that mimic the natural knee joint. The system is designed to accommodate various patient anatomies and is used in knee arthroplasty procedures to replace damaged joint surfaces.
Clinical Applications
This device is commonly used in total knee arthroplasty procedures, especially for patients with osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. It is typically utilized in orthopedic surgical settings, catering to adult and elderly populations who suffer from severe knee pain and reduced mobility. The device is crucial in restoring knee function and improving the quality of life for patients with debilitating knee conditions.
Indications for Use
The FDA-cleared indications for this device include severe knee joint degeneration due to conditions like osteoarthritis and rheumatoid arthritis. It is intended for patients who have not responded to conservative treatments and require surgical intervention to restore knee function.
Practical Considerations
The NexGen system offers various sizing options to fit different patient anatomies, ensuring optimal alignment and stability. Surgeons should be familiar with the system's components and compatibility with other surgical instruments. Proper surgical technique is essential to achieve the best outcomes and minimize complications.
Frequently Asked Questions
What is NexGen Complete Knee Solution used for?
It is used for total knee replacement in patients with severe knee joint degeneration.
What specialties typically use this device?
Orthopedic surgeons typically use this device in knee arthroplasty procedures.
What are the FDA-cleared indications?
It is indicated for severe knee joint degeneration due to conditions like osteoarthritis and 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.