đź“‹ FDA Reference
quick-start orthopaedic fixation screw and reverse thread screw
Innovate Orthopaedics
Summary: The quick-start orthopaedic fixation screw is a device used for securing bone fragments in orthopaedic surgeries. It is primarily used by orthopaedic surgeons in various surgical settings.
FDA Clearance Information
Pathway
510K
Number
K231819 ↗
Decision Date
September 5, 2023
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The quick-start orthopaedic fixation screw by Innovate Orthopaedics was cleared through the FDA's 510(k) pathway on September 5, 2023. It is a Class 2 medical device.
What It Is
This device is an orthopaedic fixation screw designed to stabilize bone fragments during surgical procedures. It features a reverse thread option for enhanced grip and stability in certain bone types. The screw is typically made from biocompatible materials and is designed for easy insertion and secure fixation, reducing the risk of loosening over time.
Clinical Applications
The quick-start orthopaedic fixation screw is commonly used in trauma surgeries, fracture repairs, and reconstructive procedures. It is particularly useful in settings where rapid and secure fixation is required, such as emergency departments and orthopaedic operating rooms. The device is suitable for a wide range of patients, including those with complex fractures or osteoporosis.
Indications for Use
The FDA-cleared indications for this device include its use in securing bone fragments in orthopaedic surgeries. It is intended for patients requiring stabilization of bone structures due to fractures or reconstructive needs.
Practical Considerations
The device comes in various sizes to accommodate different anatomical requirements and is compatible with standard orthopaedic surgical tools. Surgeons should be familiar with the reverse thread mechanism to ensure optimal fixation. Proper technique is essential to avoid complications such as screw loosening or migration.
Frequently Asked Questions
What is the quick-start orthopaedic fixation screw used for?
It is used to secure bone fragments during orthopaedic surgeries, providing stability and support for healing.
What specialties typically use this device?
Orthopaedic surgeons primarily use this device in trauma, fracture repair, and reconstructive surgeries.
What are the FDA-cleared indications?
The device is indicated for use in securing bone fragments in patients requiring stabilization due to fractures or reconstructive needs.
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.