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linksymphoknee fixed bearing ultracongruent fb uc articulating surface
Waldemar Link Gmbh & Co. Kg
Summary: The LinkSymphoKnee Fixed Bearing Ultracongruent FB UC Articulating Surface is a knee replacement device used in orthopedic surgeries. It is primarily used by orthopedic surgeons for patients requiring knee joint replacement.
FDA Clearance Information
Pathway
510K
Number
K230471 ↗
Decision Date
March 21, 2023
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The LinkSymphoKnee Fixed Bearing was cleared through the FDA 510(k) pathway on March 21, 2023. Manufactured by Waldemar Link GmbH & Co. KG, it is classified as a Class 2 device under product code JWH.
What It Is
The LinkSymphoKnee Fixed Bearing Ultracongruent FB UC Articulating Surface is a component of a knee replacement system designed to mimic the natural movement of the knee joint. It features a fixed bearing design that offers stability and durability, making it suitable for patients with severe knee arthritis or damage. The ultracongruent articulating surface provides enhanced joint congruity, potentially reducing wear and improving patient outcomes.
Clinical Applications
This device is commonly used in total knee arthroplasty procedures, particularly in patients with advanced osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. It is typically utilized in orthopedic surgical settings, including hospitals and specialized orthopedic centers. The device is suitable for adult patients who have not responded to conservative treatments and require surgical intervention to restore knee function.
Indications for Use
The FDA indications suggest this device is intended for patients with severe knee joint degeneration or damage. It is designed to replace the knee joint in individuals who experience significant pain and mobility issues due to conditions like osteoarthritis.
Practical Considerations
The LinkSymphoKnee Fixed Bearing is available in various sizes to accommodate different patient anatomies. Surgeons should consider the patient's bone quality and alignment when selecting the appropriate size. Compatibility with other components of the knee replacement system is crucial for optimal outcomes.
Frequently Asked Questions
What is LinkSymphoKnee Fixed Bearing used for?
It is used for knee joint replacement in patients with severe arthritis or joint damage.
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 with severe knee joint degeneration, such as those with osteoarthritis, 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.