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colbalt alloy orthopaedic wire
Osteonics
Summary: The cobalt alloy orthopaedic wire by Osteonics is a medical device used primarily in orthopaedic surgeries for stabilization and fixation of bone structures. It is typically used by orthopaedic surgeons in various surgical settings.
FDA Clearance Information
Pathway
510K
Number
K811500 ↗
Decision Date
June 18, 1981
Product Code
JDR
Device Class
Class 2
Evidence
0 studies
The cobalt alloy orthopaedic wire by Osteonics was cleared through the FDA 510(k) pathway on June 18, 1981. It is classified as a Class 2 medical device under product code JDR.
What It Is
This device is a wire made from cobalt alloy, designed for use in orthopaedic procedures. Its primary function is to provide stabilization and fixation of bones during surgical interventions. The cobalt alloy material offers high strength and corrosion resistance, making it suitable for long-term implantation in the human body.
Clinical Applications
Cobalt alloy orthopaedic wires are commonly used in orthopaedic surgeries such as fracture fixation, joint stabilization, and reconstructive procedures. They are particularly useful in trauma cases where bone fragments need to be held together securely. Orthopaedic surgeons in hospital operating rooms or specialized surgical centers frequently use these wires for both adult and pediatric patients.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring the stabilization and fixation of bones. It is suitable for patients undergoing orthopaedic surgeries where bone alignment and support are critical.
Practical Considerations
These wires come in various diameters to accommodate different surgical needs and anatomical considerations. They are compatible with standard orthopaedic instruments and techniques, allowing for easy integration into existing surgical protocols. Proper handling and tensioning techniques are essential to ensure optimal outcomes.
Frequently Asked Questions
What is cobalt alloy orthopaedic wire used for?
It is used for stabilization and fixation of bones in orthopaedic surgeries.
What specialties typically use this device?
Orthopaedic surgeons commonly use this device in surgical settings.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring bone stabilization and fixation.
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.