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 ?
510(k)
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.
FDA-Cleared Indications
- For internal fixation and stabilization of fractures involving small bones.
- For use when precise bone fragment alignment and fixation are required during orthopedic surgery.
Clinical Applications
- Surgical fixation of selected fractures of the hand and wrist.
- Surgical fixation of selected fractures of the foot and ankle.
- Fixation of other appropriately selected small-bone fractures when the device size and design are suitable.
- Use by orthopedic surgeons or other appropriately trained clinicians in hospital or outpatient surgical settings.
Practical Considerations
- The system is available in multiple screw sizes; the surgeon selects the diameter and length based on the bone, fracture pattern and available bone stock.
- Placement requires appropriate orthopedic instruments, imaging or direct surgical visualization, and careful drilling and screw insertion technique.
- The device is intended for single-patient use unless the labeling specifically states otherwise; resterilization and reuse should follow the manufacturer's instructions.
- MRI safety depends on the exact implant materials, configuration and labeling. The specific device and implant conditions should be checked before an MRI examination.
- As with other fracture-fixation implants, contraindications and risks may include infection, poor bone quality, inadequate reduction, implant loosening or breakage, nonunion and the need for revision surgery.
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.