đź“‹ FDA Reference
osteomed resurfacing metatarsal implant with hydroxylapatite coating
Osteomed Lp
Summary: The Osteomed resurfacing metatarsal implant is used for joint resurfacing in the foot, particularly in the metatarsal region. It is typically used by orthopedic surgeons and podiatrists in surgical settings.
FDA Clearance Information
Pathway
510K
Number
K081876 ↗
Decision Date
August 1, 2008
Product Code
KWD
Device Class
Class 2
Evidence
0 studies
The Osteomed resurfacing metatarsal implant received FDA clearance through the 510(k) pathway on August 1, 2008. It is manufactured by Osteomed Lp and classified as a Class 2 medical device.
What It Is
This device is a metatarsal implant designed for joint resurfacing, featuring a hydroxylapatite coating to enhance bone integration. It is used to replace or repair damaged joint surfaces in the foot, particularly in the metatarsal area, to relieve pain and restore function. The hydroxylapatite coating promotes better integration with the bone, potentially improving the longevity and stability of the implant.
Clinical Applications
The implant is commonly used in orthopedic and podiatric surgeries to treat conditions like arthritis or trauma that affect the metatarsal joints. It is typically used in adult patients who require joint resurfacing to alleviate pain and improve mobility. The device is suitable for use in both outpatient and inpatient surgical settings, depending on the patient's condition and the complexity of the procedure.
Indications for Use
The implant is indicated for patients with degenerative joint disease or trauma affecting the metatarsal joints. It is intended to alleviate pain and improve joint function by resurfacing the damaged area.
Practical Considerations
The implant is available in various sizes to accommodate different patient anatomies. It is important to ensure proper sizing and alignment during surgery to optimize outcomes. Surgeons should be familiar with the specific surgical techniques required for implant placement and fixation.
Frequently Asked Questions
What is the Osteomed resurfacing metatarsal implant used for?
It is used for resurfacing damaged joint surfaces in the metatarsal region of the foot to alleviate pain and restore function.
What specialties typically use this device?
Orthopedic surgeons and podiatrists typically use this device in surgical procedures involving the foot.
What are the FDA-cleared indications?
The device is indicated for joint resurfacing in patients with degenerative joint disease or trauma affecting the metatarsal joints.
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.