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avanti orthopaedics 2 2mm and 2 7mm cannulated screws avanti orthopaedics 3 2mm and 4 0mm cannulated screws
Avanti Orthopaedics
Summary: The Avanti Orthopaedics cannulated screws are used in orthopedic surgeries for internal fixation of fractures. They are typically used by orthopedic surgeons in various settings.
FDA Clearance Information
Pathway
510K
Number
K222967 ↗
Decision Date
November 23, 2022
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Avanti Orthopaedics cannulated screws were cleared through the FDA 510k pathway on November 23, 2022. Manufactured by Avanti Orthopaedics, these devices are classified as Class 2 under product code HWC.
What It Is
These are cannulated screws designed for orthopedic surgical procedures, primarily used for internal fixation of bone fractures. The screws are hollow, allowing for the insertion of a guide wire to ensure accurate placement. Available in sizes of 2.2mm, 2.7mm, 3.2mm, and 4.0mm, they provide versatility in treating various fracture types.
Clinical Applications
Cannulated screws are commonly used in orthopedic surgeries, such as the fixation of small bone fractures, including those in the wrist, ankle, and foot. They are particularly useful in minimally invasive procedures due to their design, which allows for precise placement with minimal tissue disruption. These devices are typically used in hospital operating rooms or specialized orthopedic clinics.
Indications for Use
The FDA indications suggest these screws are intended for use in the fixation of bone fractures. They are suitable for patients with fractures requiring internal fixation, such as those resulting from trauma or degenerative conditions.
Practical Considerations
These screws come in various sizes to accommodate different fracture types and anatomical locations. They are compatible with standard orthopedic surgical instruments and techniques. Surgeons should consider the specific fracture pattern and patient anatomy when selecting the appropriate screw size.
Frequently Asked Questions
What is Avanti cannulated screws used for?
They are used for the internal fixation of bone fractures, providing stability and support during the healing process.
What specialties typically use this device?
Orthopedic surgeons primarily use these devices in surgical settings to treat fractures.
What are the FDA-cleared indications?
The screws are indicated for the fixation of bone fractures, suitable for various fracture types and patient populations.
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.