📋 FDA Reference
Mtp Resesurfacing Joint-Small 9301-01 Medium 9301-02 Large 9301-03
Terray
Summary: The mtp Resurfacing Joint by Terray is a medical device used for joint resurfacing, primarily in the treatment of small joint conditions. It is typically utilized by orthopedic surgeons and podiatrists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K003629 ↗
Decision Date ?
February 22, 2001
Product Code ?
KWD
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510k pathway on February 22, 2001. Manufactured by Terray, it is classified as a Class 2 device under product code KWD.
What It Is
The mtp Resurfacing Joint is a prosthetic device designed to resurface small joints, such as those in the fingers or toes. It is used to alleviate pain and restore function in joints affected by conditions such as arthritis or trauma. The device is available in small, medium, and large sizes to accommodate different anatomical needs.
FDA-Cleared Indications
- Resurfacing of small joints when indicated by the patient's joint condition and anatomy.
- Use in metatarsophalangeal joint surgery to address joint pain and dysfunction associated with the labeled condition.
- Use in adult patients requiring a small-joint resurfacing prosthesis.
Clinical Applications
- Small-joint resurfacing surgery.
- Metatarsophalangeal joint resurfacing.
- Treatment of small-joint degeneration or deformity when resurfacing is clinically indicated.
- Reconstruction intended to reduce pain and preserve joint motion.
Practical Considerations
- The device is listed in small, medium, and large sizes: 9301-01, 9301-02, and 9301-03.
- Size selection should be based on the patient's anatomy and the operative technique.
- The record identifies the device as a Class II device cleared through the 510(k) pathway under product code KWD.
- The FDA record provided does not specify MRI safety or conditional-use labeling; MRI status should be confirmed in the current manufacturer labeling before scanning.
- Contraindications, implant longevity, surgical technique, and compatibility should be confirmed in the current instructions for use.
Frequently Asked Questions
What is mtp Resurfacing Joint used for?
It is used for resurfacing small joints to alleviate pain and improve function in conditions like arthritis.
What specialties typically use this device?
Orthopedic surgeons and podiatrists commonly use this device.
What are the FDA-cleared indications?
It is indicated for joint resurfacing in patients with conditions such as arthritis or joint deformities.
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.