📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Stabilization and fixation of bone during orthopaedic surgery.
- Use in procedures requiring maintenance of bone alignment and structural support.
Clinical Applications
- Fixation of bone fragments during fracture surgery.
- Stabilization of bones during reconstructive orthopaedic procedures.
- Bone fixation when wire-based stabilization is selected by the orthopaedic surgeon.
Practical Considerations
- The wire is available in different diameters; the appropriate size depends on the bone, surgical technique and fixation requirements.
- The wire is used with standard orthopaedic instruments and must be properly placed, tensioned, cut and secured.
- Cobalt alloy is intended for implantation, but patients with known metal hypersensitivity should be evaluated before use.
- MRI safety depends on the specific device configuration and labeling. The implant should be identified and assessed under current MRI safety guidance before scanning.
- Potential complications include infection, loosening, migration, breakage, tissue irritation and the need for revision or removal.
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.