đź“‹ FDA Reference
Orthomed Orthopaedic Fixation Staples
Biomedical Exports
Summary: Orthomed Orthopaedic Fixation Staples are used for stabilizing bone fragments in orthopedic surgeries. They are primarily used by orthopedic surgeons in various fracture fixation procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K861137 ↗
Decision Date ?
April 17, 1986
Product Code ?
JDR
Device Class ?
Class 2
Evidence ?
0 studies
The Orthomed Orthopaedic Fixation Staples were cleared through the FDA 510(k) pathway on April 17, 1986. Manufactured by Biomedical Exports, this device is classified as Class 2 under product code JDR.
What It Is
Orthomed Orthopaedic Fixation Staples are medical devices designed to stabilize and fixate bone fragments during orthopedic surgeries. These staples are typically made of biocompatible materials and are used to maintain proper alignment of bones during the healing process. They work by providing mechanical support and compression to fractured or osteotomized bone segments.
FDA-Cleared Indications
- Stabilization and fixation of bone fragments during orthopedic surgery.
- Maintenance of alignment and mechanical support for fractured or surgically divided bone segments.
- Use in orthopedic fixation procedures when a staple is appropriate for the anatomy and required fixation.
Clinical Applications
- Fixation of selected bone fractures.
- Fixation of osteotomies performed to correct bone alignment or deformity.
- Stabilization of small bones or bone fragments in the hand or foot when appropriate.
- Fixation during selected orthopedic reconstructive procedures.
Practical Considerations
- Staples are available in different sizes and configurations; selection depends on bone size, fracture pattern, surgical approach, and the required compression or stability.
- Placement requires accurate preparation and positioning with compatible orthopedic instruments.
- The implant material and configuration should be confirmed before MRI. MRI safety is not established from the available record alone, so the device's current labeling and implant documentation should be reviewed.
- Potential contraindications include active infection, inadequate bone quality or size for fixation, and situations in which the staple cannot provide sufficient stability.
- The surgeon should follow the manufacturer's instructions for implantation, handling, postoperative care, and any need for removal.
Frequently Asked Questions
What is Orthomed Orthopaedic Fixation Staples used for?
Orthomed Orthopaedic Fixation Staples are used for stabilizing and fixating bone fragments during orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons typically use this device in fracture fixation and reconstructive surgeries.
What are the FDA-cleared indications?
The FDA-cleared indications include the stabilization of bone fragments in orthopedic conditions such as fractures and osteotomies.
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.