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arthrosurface wristmotion total wrist arthroplasty system
Arthrosurface
Summary: The Arthrosurface WristMotion Total Wrist Arthroplasty System is a surgical implant used to replace the wrist joint. It is primarily used by orthopedic surgeons to treat patients with severe wrist arthritis or joint damage.
FDA Clearance Information
Pathway
510K
Number
K200718 ↗
Decision Date
October 15, 2020
Product Code
JWJ
Device Class
Class 2
Evidence
0 studies
The Arthrosurface WristMotion Total Wrist Arthroplasty System was cleared through the FDA 510(k) pathway on October 15, 2020. Manufactured by Arthrosurface, it is classified as a Class 2 device under product code JWJ.
What It Is
The Arthrosurface WristMotion Total Wrist Arthroplasty System is a medical device designed to replace the wrist joint, providing pain relief and restoring function in patients with severe arthritis or joint damage. The system includes components that mimic the natural anatomy of the wrist, allowing for a range of motion similar to that of a healthy joint. This device is typically implanted during a surgical procedure by an orthopedic surgeon.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly in cases where patients suffer from debilitating wrist arthritis or trauma that has severely compromised joint function. It is suitable for adult patients who have not responded to conservative treatments and require surgical intervention to regain mobility and reduce pain. The device is typically used in hospital settings or specialized orthopedic centers.
Indications for Use
The FDA-cleared indications for this device include the treatment of patients with severe wrist arthritis or joint damage that has not improved with non-surgical treatments. It is intended for those who experience significant pain and loss of function in the wrist joint.
Practical Considerations
The Arthrosurface WristMotion System comes in various sizes to accommodate different patient anatomies. Surgeons should be familiar with the surgical technique and ensure compatibility with the patient's bone structure. Preoperative planning and imaging are essential to achieve optimal outcomes.
Frequently Asked Questions
What is the Arthrosurface WristMotion Total Wrist Arthroplasty used for?
It is used to replace the wrist joint in patients with severe arthritis or joint damage to relieve pain and restore function.
What specialties typically use this device?
Orthopedic surgeons specializing in hand and wrist surgery typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with severe wrist arthritis or joint damage who have not responded to non-surgical treatments.
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.