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 ?
510(k)
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.
FDA-Cleared Indications
- Resurfacing of the great toe metatarsophalangeal joint in patients with degenerative joint disease.
- Resurfacing of the great toe metatarsophalangeal joint in patients with deformity.
Clinical Applications
- Great toe joint resurfacing during orthopedic surgery.
- Treatment of degenerative disease affecting the great toe metatarsophalangeal joint.
- Treatment of a painful or function-limiting great toe joint deformity when joint resurfacing is selected.
- Use in adult patients with degenerative or deforming conditions of the great toe joint, based on clinical evaluation and product labeling.
Practical Considerations
- The surgeon should select component sizes and positioning based on the patient's anatomy and the manufacturer’s surgical technique.
- Confirm that the available instruments and implant components are compatible before surgery.
- Patient selection should account for bone quality, deformity, infection risk, activity level and other factors that can affect implant fixation or joint function.
- MRI safety and artifact information should be confirmed in the current manufacturer’s instructions for use; this record does not establish that the implant is MR Safe or MR Conditional.
- The device should be used only by appropriately trained clinicians and according to the current labeling. Contraindications and warnings should be reviewed before implantation.
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.