đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Stabilization and fixation of bone fragments during orthopedic surgery.
- Use in patients who require internal fixation to maintain bone alignment and support healing.
- Use with compatible orthopedic instruments and surgical techniques specified in the device labeling.
Clinical Applications
- Internal fixation of bone fractures.
- Stabilization of bone fragments after traumatic injury.
- Fixation during reconstructive orthopedic procedures when internal screw fixation is indicated.
Practical Considerations
- The screw is available in different sizes; the surgeon selects the diameter and length based on the bone, fracture pattern and required fixation.
- The reverse-thread or quick-start design requires appropriate insertion technique and compatible instruments.
- MRI safety depends on the specific screw materials, configuration and labeling. The device should be treated as MRI-conditional or unknown unless the current manufacturer labeling confirms otherwise.
- Contraindications and precautions may include active infection, inadequate bone quality, insufficient bone stock, allergy to device materials and inability to follow postoperative restrictions.
- The device is intended for use by trained orthopedic professionals; the FDA clearance does not establish that it is appropriate for every fracture or reconstructive procedure.
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.