đź“‹ FDA Reference
cap great toe resurfacing hemi-arthroplasty implant
Arthrosurface
Summary: The CAP Great Toe Resurfacing Implant by Arthrosurface is used in hemi-arthroplasty procedures to treat arthritis in the great toe. It is typically used by orthopedic surgeons specializing in foot and ankle surgery.
FDA Clearance Information
Pathway
510K
Number
K031859 ↗
Decision Date
February 18, 2004
Product Code
KWD
Device Class
Class 2
Evidence
0 studies
The CAP Great Toe Resurfacing Implant was cleared through the FDA 510(k) pathway on February 18, 2004. It is manufactured by Arthrosurface and classified as a Class 2 medical device.
What It Is
The CAP Great Toe Resurfacing Implant is a hemi-arthroplasty device designed to replace the damaged surface of the great toe joint. It consists of a metal cap that resurfaces the joint, providing pain relief and improved function. The implant is typically used when conservative treatments for arthritis have failed, and it aims to preserve as much of the patient's natural anatomy as possible.
Clinical Applications
This device is commonly used in orthopedic procedures to treat hallux rigidus, a form of degenerative arthritis affecting the great toe. It is particularly useful in patients who experience pain and limited motion in the toe joint. The implant is typically used in outpatient surgical settings by orthopedic surgeons, particularly those specializing in foot and ankle surgery.
Indications for Use
The FDA-cleared indications for this device include the treatment of arthritis in the great toe, specifically in cases where the joint surface is damaged but the underlying bone structure is still viable. It is intended for patients who have not responded to non-surgical treatments.
Practical Considerations
The CAP Great Toe Resurfacing Implant is available in various sizes to accommodate different patient anatomies. Surgeons should ensure proper sizing and alignment during implantation to optimize outcomes. Compatibility with existing surgical instruments and techniques should be considered during preoperative planning.
Frequently Asked Questions
What is the CAP Great Toe Resurfacing Implant used for?
It is used for hemi-arthroplasty procedures to treat arthritis in the great toe, providing pain relief and improved joint function.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in foot and ankle surgery, typically use this device.
What are the FDA-cleared indications?
The device is indicated for treating arthritis in the great toe, especially when the joint surface is damaged but the bone structure is still viable.
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.