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fms vue fluid managment system fms connect interface cable
Depuy Mitek, A Johnson & Johnson
Summary: The FMS Vue Fluid Management System is a device used in surgical procedures to manage fluid levels, typically in arthroscopic surgeries. It is primarily used by orthopedic surgeons to ensure clear visibility and maintain joint distension.
FDA Clearance Information
Pathway
510K
Number
K130169 ↗
Decision Date
May 1, 2013
Product Code
HRX
Device Class
Class 2
Evidence
0 studies
The FMS Vue Fluid Management System, manufactured by Depuy Mitek, was cleared through the FDA 510(k) pathway on May 1, 2013. It is classified as a Class 2 device under product code HRX.
What It Is
The FMS Vue Fluid Management System is designed to control fluid inflow and outflow during surgical procedures, particularly arthroscopies. It helps maintain a clear surgical field by managing the pressure and flow of fluids within a joint. This system is crucial for procedures where visibility and joint distension are necessary for effective surgical intervention.
Clinical Applications
This device is commonly used in orthopedic surgeries, especially arthroscopic procedures such as knee, shoulder, and hip arthroscopies. It is utilized in both hospital and outpatient surgical settings. The system is beneficial for patients undergoing minimally invasive surgeries where precise fluid management is critical for procedural success.
Indications for Use
The FDA indications for the FMS Vue Fluid Management System include its use in managing fluid levels during surgical procedures, particularly for maintaining joint distension and visibility in arthroscopic surgeries. It is suitable for patients undergoing procedures that require controlled fluid environments.
Practical Considerations
The FMS Vue system is compatible with various arthroscopic instruments and typically integrates with existing surgical setups. Clinicians should ensure proper calibration and setup to optimize fluid management. The system's interface cable, FMS Connect, facilitates seamless integration with other surgical devices.
Frequently Asked Questions
What is the FMS Vue Fluid Management System used for?
It is used to manage fluid levels during arthroscopic surgeries, ensuring clear visibility and maintaining joint distension.
What specialties typically use this device?
Orthopedic surgeons primarily use this device during arthroscopic procedures.
What are the FDA-cleared indications?
The device is indicated for managing fluid levels in surgical procedures, particularly to maintain joint distension and visibility in arthroscopies.
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.