đź“‹ FDA Reference
field orthopaedics micro screw system
Field Orthopaedics Pty
Summary: The Field Orthopaedics Micro Screw System is a medical device used in orthopedic procedures to provide stable fixation in small bone fractures. It is typically used by orthopedic surgeons in settings requiring precise and reliable bone anchorage.
FDA Clearance Information
Pathway
510K
Number
K180348 ↗
Decision Date
July 17, 2018
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Field Orthopaedics Micro Screw System was cleared through the FDA 510(k) pathway on July 17, 2018. Manufactured by Field Orthopaedics Pty, it is classified as a Class 2 device under product code HWC.
What It Is
The Field Orthopaedics Micro Screw System is designed for use in orthopedic surgeries to stabilize small bone fractures. These micro screws provide reliable fixation, enhancing the healing process by maintaining the proper alignment of bone fragments. The system is particularly useful in delicate procedures where precision is crucial.
Clinical Applications
This device is commonly used in orthopedic surgeries involving small bones, such as those in the hands and feet. It is particularly beneficial in trauma cases where small, precise fixation is required. Orthopedic surgeons and podiatrists frequently use this system in both hospital and outpatient surgical settings.
Indications for Use
The FDA indications suggest this device is intended for use in stabilizing small bone fractures. It is suitable for patients with fractures in areas requiring precise fixation, such as the hands, feet, or other small bones.
Practical Considerations
The micro screw system typically comes in various sizes to accommodate different fracture types and locations. It is compatible with standard orthopedic surgical instruments, and careful technique is required to ensure proper placement and fixation.
Related Literature
The linked study titled 'Modern Anchorage Systems in Orthodontics' explores the use of temporary anchorage devices in orthodontics. It highlights the shift from conventional anchorage methods to skeletal anchorage, which offers improved stability and fewer side effects. Although not directly related to the micro screw system, the study underscores the importance of stable anchorage in medical procedures. Limitations include its focus on orthodontics rather than orthopedic applications.
Frequently Asked Questions
What is the Field Orthopaedics Micro Screw System used for?
It is used for stabilizing small bone fractures in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons and podiatrists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for stabilizing small bone fractures, particularly in areas requiring precise fixation.
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.