📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Resurfacing of an affected metatarsal joint surface during surgical treatment of metatarsal joint disease.
- Use in patients whose metatarsal joint requires surgical reconstruction, according to the cleared device labeling.
Clinical Applications
- Metatarsal joint resurfacing during foot surgery.
- Surgical treatment of a damaged or diseased metatarsal joint.
- Reconstruction of the metatarsal joint using an appropriately sized implant.
Practical Considerations
- The surgeon must select the implant size and configuration appropriate for the patient's anatomy and bone quality.
- The implant should be used with compatible surgical instruments and according to the manufacturer's surgical technique.
- Patient factors such as infection, inadequate bone stock, poor soft-tissue coverage, or other causes of implant instability may affect suitability; the treating surgeon evaluates contraindications.
- MRI safety and conditions are not established by the information provided here. Patients should identify the implant before MRI and follow the manufacturer's current MRI labeling.
- As with other orthopedic implants, possible complications include infection, loosening, malposition, fracture, persistent pain, limited motion, and the need for revision surgery.
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.