đź“‹ FDA Reference
hemicap mtp resurfacing hemi-arthroplasty implant
Arthrosurface
Summary: The HemiCAP MTP Resurfacing Implant is a surgical device used in hemi-arthroplasty to treat joint surface damage in the metatarsophalangeal (MTP) joint. It is primarily used by orthopedic surgeons to alleviate pain and restore function in patients with arthritis or joint degeneration.
FDA Clearance Information
Pathway
510K
Number
K131377 ↗
Decision Date
November 19, 2013
Product Code
KWD
Device Class
Class 2
Evidence
0 studies
The HemiCAP MTP Resurfacing Implant, manufactured by Arthrosurface, received FDA clearance through the 510(k) pathway on November 19, 2013. It is classified as a Class 2 medical device under product code KWD.
What It Is
The HemiCAP MTP Resurfacing Implant is a partial joint replacement device designed to resurface the metatarsophalangeal joint, typically the big toe. It consists of a contoured metal cap that fits over the damaged cartilage and bone, providing a smooth, durable surface for joint movement. This device aims to relieve pain and improve mobility in patients with localized joint degeneration or arthritis.
Clinical Applications
This implant is commonly used in orthopedic and podiatric settings for patients with hallux rigidus or other degenerative conditions of the MTP joint. It is particularly beneficial for active patients who experience joint pain but wish to maintain mobility. The procedure is typically performed in outpatient surgical centers or hospitals, and it is an alternative to more invasive joint fusion surgeries.
Indications for Use
The FDA-cleared indications for the HemiCAP MTP Resurfacing Implant include treatment of localized cartilage damage or arthritis in the metatarsophalangeal joint. It is intended for patients who have not responded to conservative treatments and are experiencing significant pain and mobility issues.
Practical Considerations
The implant comes in various sizes to accommodate different patient anatomies, ensuring a proper fit. Surgeons should be familiar with the specific surgical technique required for implantation, including the use of specialized instruments for precise placement. Compatibility with existing joint structures is critical for optimal outcomes.
Frequently Asked Questions
What is the HemiCAP MTP Resurfacing Implant used for?
It is used to treat joint surface damage in the metatarsophalangeal joint, often due to arthritis or degeneration, to relieve pain and improve function.
What specialties typically use this device?
Orthopedic surgeons and podiatrists commonly use this device for patients with MTP joint issues.
What are the FDA-cleared indications?
The device is indicated for patients with localized cartilage damage or arthritis in the MTP joint who have not responded to other 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.