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edge orthopaedics bite compression screw
Icon Orthopaedic Concepts Dba Edge Orthopaedics
Summary: The Edge Orthopaedics Bite Compression Screw is a medical device used primarily in orthopedic surgeries to stabilize bone fragments. It is typically utilized by orthopedic surgeons in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K132893 ↗
Decision Date
November 20, 2013
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Edge Orthopaedics Bite Compression Screw was cleared via the FDA 510(k) pathway on November 20, 2013. Manufactured by Icon Orthopaedic Concepts, it is classified as a Class 2 device under product code HWC.
What It Is
The Edge Orthopaedics Bite Compression Screw is designed for use in orthopedic procedures to provide compression and stabilization of bone fragments. It is typically used in fracture management, where maintaining alignment and promoting healing are critical. The screw's design allows for effective compression across fracture sites, which is essential for proper bone healing.
Clinical Applications
This device is commonly used in orthopedic and trauma surgery settings, particularly in procedures involving fractures of long bones such as the femur or tibia. It is suitable for both adult and pediatric populations, depending on the specific fracture and patient needs. Orthopedic surgeons may use this device in both hospital and outpatient surgical centers.
Indications for Use
The FDA indications suggest that this device is intended for use in stabilizing bone fragments in fractures. It is particularly useful in cases where compression of the fracture site is necessary to promote healing and ensure proper alignment.
Practical Considerations
The Edge Orthopaedics Bite Compression Screw comes in various sizes to accommodate different fracture types and patient anatomies. It is important for clinicians to select the appropriate size and ensure compatibility with other surgical instruments and implants. Proper surgical technique is essential to maximize the device's effectiveness.
Frequently Asked Questions
What is the Edge Orthopaedics Bite Compression Screw used for?
It is used to stabilize and compress bone fragments in fractures, aiding in proper alignment and healing.
What specialties typically use this device?
Orthopedic surgeons primarily use this device in trauma and fracture management surgeries.
What are the FDA-cleared indications?
The device is indicated for use in stabilizing bone fragments in fractures, particularly where compression is needed.
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.