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cobalt-chromium-molybdenum co-cr-mo alloy femoral heads w co-nidium surface treatment
Zimmer
Summary: The cobalt-chromium-molybdenum alloy femoral heads with Co-Nidium surface treatment are orthopedic implants used in hip replacement surgeries. They are primarily utilized by orthopedic surgeons to improve joint function in patients with hip joint degeneration.
FDA Clearance Information
Pathway
510K
Number
K960278 ↗
Decision Date
July 25, 1996
Product Code
JDI
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on July 25, 1996. Manufactured by Zimmer, it is classified as a Class 2 device under product code JDI.
What It Is
The cobalt-chromium-molybdenum alloy femoral heads are components used in hip arthroplasty. They are designed to replace the femoral head in hip joint replacements, providing a durable and biocompatible surface. The Co-Nidium surface treatment enhances wear resistance, reducing the risk of implant degradation over time.
Clinical Applications
These femoral heads are commonly used in total hip replacement surgeries, particularly in patients with osteoarthritis, rheumatoid arthritis, or traumatic hip injuries. They are typically employed in orthopedic surgical settings, catering to adult and elderly populations who require joint replacement to restore mobility and alleviate pain.
Indications for Use
The device is indicated for use in patients requiring hip joint replacement due to degenerative joint diseases or trauma. It is suitable for individuals experiencing severe hip pain and mobility issues that have not responded to conservative treatments.
Practical Considerations
These femoral heads come in various sizes to accommodate different patient anatomies and are compatible with a range of acetabular components. Surgeons should consider the patient's bone quality and activity level when selecting the appropriate size and type of implant.
Frequently Asked Questions
What is cobalt-chromium-molybdenum femoral heads used for?
They are used in hip replacement surgeries to replace the femoral head, improving joint function and reducing pain.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and reconstructive surgery commonly use this device.
What are the FDA-cleared indications?
The device is indicated for hip joint replacement in patients with degenerative joint diseases or trauma.
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.