đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Used for internal fixation and stabilization of bone fragments.
- Used when compression across a fracture or osteotomy site is required.
- Intended for use in orthopedic surgical procedures according to the manufacturer’s labeling and compatible instrumentation.
Clinical Applications
- Compression fixation of selected bone fractures.
- Stabilization of bone fragments after reduction during orthopedic surgery.
- Fixation of selected osteotomy sites when compression is indicated.
- Use with compatible surgical instruments and implants according to the device labeling.
Practical Considerations
- The appropriate screw diameter and length must be selected for the bone, fracture pattern, and patient anatomy.
- The screw should be used only with compatible instruments and implants specified by the manufacturer.
- Correct reduction, screw trajectory, depth, and compression are important to avoid loss of fixation or injury to nearby structures.
- Contraindications and precautions may include infection, inadequate bone stock, severe bone loss, or inability to follow postoperative restrictions; the complete labeling should be reviewed.
- MRI safety depends on the exact implant material, configuration, and labeling. Do not assume the device is MRI safe or MRI conditional without confirming the current manufacturer’s instructions.
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.