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osteomed metatarsal resurfacing implant system
Osteomed Lp
Summary: The Osteomed Metatarsal Resurfacing Implant System is a surgical device used for resurfacing the metatarsal bones in the foot. It is primarily used by orthopedic surgeons to treat conditions like arthritis or deformities in the metatarsal region.
FDA Clearance Information
Pathway
510K
Number
K073065 ↗
Decision Date
February 21, 2008
Product Code
KWD
Device Class
Class 2
Evidence
0 studies
The Osteomed Metatarsal Resurfacing Implant System was cleared through the FDA 510(k) pathway on February 21, 2008. Manufactured by Osteomed Lp, it is classified as a Class 2 device under product code KWD.
What It Is
This device is a surgical implant designed to resurface the metatarsal bones of the foot. It is typically used to address conditions such as arthritis or structural deformities that affect the metatarsal region. The implant helps restore joint function and alleviate pain by providing a smooth surface for articulation. It is made from biocompatible materials suitable for long-term implantation.
Clinical Applications
The Osteomed Metatarsal Resurfacing Implant System is commonly used in orthopedic and podiatric surgery. It is particularly useful in procedures aimed at correcting metatarsal deformities or treating degenerative joint diseases like arthritis. The device is typically used in hospital or outpatient surgical settings and is suitable for adult patients experiencing metatarsal pain or dysfunction.
Indications for Use
This device is indicated for patients with metatarsal joint issues, such as arthritis or deformities, that require surgical intervention. It is designed to improve joint function and reduce pain by resurfacing the affected metatarsal bones.
Practical Considerations
The implant comes in various sizes to accommodate different patient anatomies. Surgeons should ensure compatibility with existing surgical instruments and consider the patient's bone quality when selecting the implant size. Proper surgical technique is crucial for optimal outcomes.
Frequently Asked Questions
What is the Osteomed Metatarsal Resurfacing Implant System used for?
It is used to resurface the metatarsal bones in the foot, typically to treat arthritis or deformities.
What specialties typically use this device?
Orthopedic and podiatric surgeons commonly use this device in their practices.
What are the FDA-cleared indications?
The device is indicated for patients with metatarsal joint issues, such as arthritis or deformities, requiring surgical intervention.
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.