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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
510K
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.
Clinical Applications
These staples are commonly used in orthopedic procedures such as fracture fixation, osteotomies, and reconstructive surgeries. They are particularly useful in settings where rigid fixation is required, such as in the treatment of hand, foot, or small bone fractures. Orthopedic surgeons in hospitals and specialized clinics frequently use these devices for patients with traumatic injuries or congenital deformities.
Indications for Use
The FDA indications for Orthomed Orthopaedic Fixation Staples include their use in stabilizing bone fragments in various orthopedic conditions. They are suitable for patients with fractures or those undergoing corrective bone surgeries.
Practical Considerations
Orthomed Orthopaedic Fixation Staples come in various sizes to accommodate different bone structures and surgical needs. They are compatible with standard orthopedic instruments and require precise placement for optimal results. Surgeons should consider the specific anatomical and biomechanical requirements of each case when selecting the appropriate staple size and configuration.
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.