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quick-start orthopaedic fixation screw and reverse thread screw
Innovate Orthopaedics
Summary: The quick-start orthopaedic fixation screw is used for stabilizing bone fractures. It is typically utilized by orthopedic surgeons in various surgical settings.
FDA Clearance Information
Pathway
510K
Number
K242442 ↗
Decision Date
January 31, 2025
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The quick-start orthopaedic fixation screw by Innovate Orthopaedics was cleared through the FDA 510k pathway on January 31, 2025. It is a Class 2 medical device.
What It Is
The quick-start orthopaedic fixation screw is a medical device designed to stabilize bone fragments in orthopedic surgeries. It features a reverse thread design that enhances grip and stability in bone tissue. This device is particularly useful in procedures requiring precise alignment and fixation of bone fragments.
Clinical Applications
This device is commonly used in orthopedic surgeries such as fracture repair, spinal fusion, and joint stabilization. Orthopedic surgeons in hospital and outpatient surgical settings frequently employ this screw for its ease of use and reliable performance. It is suitable for a wide range of patients, including those with traumatic injuries or degenerative bone conditions.
Indications for Use
The FDA-cleared indications suggest that this device is intended for patients requiring bone stabilization, such as those with fractures or undergoing reconstructive surgeries. It is particularly beneficial in cases where enhanced fixation is necessary.
Practical Considerations
The quick-start orthopaedic fixation screw comes in various sizes to accommodate different anatomical requirements. It is compatible with standard orthopedic surgical instruments and requires familiarity with reverse thread insertion techniques for optimal performance.
Frequently Asked Questions
What is the quick-start orthopaedic fixation screw used for?
It is used for stabilizing bone fractures and aiding in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in surgical settings.
What are the FDA-cleared indications?
It is indicated for patients needing bone stabilization, such as those with fractures or undergoing reconstructive surgery.
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.