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hemicap mtp resurfacing hemi-arthroplasty system
Arthrosurface
Summary: The HemiCAP MTP Resurfacing Hemi-Arthroplasty System is a surgical implant used in the treatment of toe joint arthritis. It is typically used by orthopedic surgeons specializing in foot and ankle procedures.
FDA Clearance Information
Pathway
510K
Number
K152454 ↗
Decision Date
April 11, 2016
Product Code
KWD
Device Class
Class 2
Evidence
0 studies
The HemiCAP MTP Resurfacing Hemi-Arthroplasty System was cleared through the FDA 510(k) pathway on April 11, 2016. Manufactured by Arthrosurface, it is classified as a Class 2 medical device.
What It Is
The HemiCAP MTP Resurfacing Hemi-Arthroplasty System is an implant designed to resurface the metatarsophalangeal (MTP) joint, commonly the big toe joint. It consists of a contoured cap and fixation component that fits the patient's anatomy, providing a smooth surface for joint articulation. This device aims to relieve pain and restore function in patients with degenerative joint disease or arthritis in the toe.
Clinical Applications
This device is commonly used in orthopedic and podiatric surgical settings, particularly for patients suffering from hallux rigidus or severe arthritis of the big toe. It is often considered when conservative treatments fail, and joint preservation is preferred over joint fusion. The typical patient population includes adults with advanced arthritis seeking pain relief and improved mobility.
Indications for Use
The FDA-cleared indications for this device include resurfacing the MTP joint in patients with arthritis or degenerative joint disease. It is intended for individuals experiencing significant pain and reduced joint function.
Practical Considerations
The HemiCAP system offers various sizing options to accommodate different patient anatomies. It requires precise surgical technique to ensure proper alignment and fixation. Compatibility with existing surgical instruments is generally good, but specific training on the system may be beneficial.
Frequently Asked Questions
What is the HemiCAP MTP Resurfacing Hemi-Arthroplasty System used for?
It is used for resurfacing the MTP joint in patients with arthritis or degenerative joint disease to relieve pain and restore joint function.
What specialties typically use this device?
Orthopedic surgeons and podiatrists specializing in foot and ankle surgery typically use this device.
What are the FDA-cleared indications?
The device is indicated for resurfacing the MTP joint in patients with arthritis or degenerative joint disease, particularly when conservative treatments have failed.
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.