đź“‹ FDA Reference
merete toemobile anatomical great toe resurfacing system
Merete Medical
Summary: The Merete Toemobile Anatomical Great Toe Resurfacing System is a medical device used for great toe joint resurfacing. It is primarily used by orthopedic surgeons to treat conditions affecting the great toe joint.
FDA Clearance Information
Pathway
510K
Number
K072251 ↗
Decision Date
May 8, 2008
Product Code
LZJ
Device Class
—
Evidence
0 studies
The Merete Toemobile Anatomical Great Toe Resurfacing System was cleared through the FDA 510(k) pathway on May 8, 2008. It is manufactured by Merete Medical and does not have a specific device classification.
What It Is
The Merete Toemobile Anatomical Great Toe Resurfacing System is designed to resurface the joint of the great toe. It provides a solution for patients suffering from degenerative joint diseases or deformities in the great toe. The device aims to restore joint function and alleviate pain by resurfacing the affected area with anatomically designed components.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly in procedures addressing hallux rigidus or arthritis of the great toe. It is suitable for use in both hospital and outpatient surgical settings. The typical patient population includes adults experiencing pain and reduced mobility due to degenerative conditions of the great toe joint.
Indications for Use
The FDA-cleared indications suggest this device is intended for patients with degenerative joint disease or deformities of the great toe. It is particularly useful for those experiencing pain and limited function due to these conditions.
Practical Considerations
Clinicians should consider the anatomical fit and sizing options available with the device to ensure optimal outcomes. Compatibility with existing surgical instruments and techniques should be verified prior to use. Proper patient selection and surgical technique are critical for success.
Frequently Asked Questions
What is the Merete Toemobile Anatomical Great Toe Resurfacing System used for?
It is used for resurfacing the great toe joint to treat degenerative joint diseases and deformities.
What specialties typically use this device?
Orthopedic surgeons typically use this device in procedures related to the great toe joint.
What are the FDA-cleared indications?
The device is indicated for patients with degenerative joint disease or deformities of the great toe, aiming to restore function and alleviate pain.
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.