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riopro cobalt trapeziometarcarpal resurfacing component
Biologically Oriented Prostheses
Summary: The riopro cobalt trapeziometarcarpal resurfacing component is a medical device used in joint resurfacing procedures, primarily for the thumb's base joint. It is used by orthopedic surgeons to address conditions like arthritis.
FDA Clearance Information
Pathway
510K
Number
K964472 ↗
Decision Date
February 3, 1997
Product Code
KYI
Device Class
Class 2
Evidence
0 studies
The riopro cobalt trapeziometarcarpal resurfacing component was cleared through the FDA 510k pathway on February 3, 1997. It is manufactured by Biologically Oriented Prostheses and is classified as a Class 2 device.
What It Is
The riopro cobalt trapeziometarcarpal resurfacing component is designed to resurface the trapeziometacarpal joint, commonly affected by osteoarthritis. Made from cobalt, it provides a durable surface to replace damaged cartilage, aiming to reduce pain and improve joint function. This device is typically used in surgical procedures to restore mobility and alleviate discomfort in the thumb's base joint.
Clinical Applications
This device is commonly used in orthopedic and hand surgery settings, particularly for patients suffering from basal joint arthritis of the thumb. It is suitable for adult patients experiencing pain and reduced function due to degenerative joint disease. The procedure is typically performed in a hospital or outpatient surgical center by orthopedic surgeons specializing in hand surgery.
Indications for Use
The FDA-cleared indications for this device include the treatment of patients with trapeziometacarpal joint arthritis. It is intended for individuals who have not responded adequately to conservative treatments and require surgical intervention to restore joint function.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies. Surgeons should ensure compatibility with existing bone structures and consider the patient's activity level when selecting the appropriate size. Proper surgical technique is crucial for optimal outcomes and longevity of the implant.
Frequently Asked Questions
What is riopro cobalt trapeziometarcarpal used for?
It is used for resurfacing the trapeziometacarpal joint to treat arthritis and improve joint function.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in hand surgery, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with trapeziometacarpal joint arthritis who require surgical intervention.
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.