FMS Duo
by Future Medical Systems, Inc. 510(k)
Active
510(k) K954465
Overview
The FMS Duo is an Arthroscopy Fluid Management System (Product Code: HRX), designed for precise irrigation and fluid control during orthopedic arthroscopic procedures. It integrates fluid management with an integrated shaver system to enhance surgical efficiency and visualization by maintaining optimal fluid pressure and flow.
This device is supplied as a reusable medical instrument, intended for use in orthopedic surgical settings. It is cleared by the FDA under 510(k) (K954465) as substantially equivalent to existing orthopedic fluid management systems. No specific sterility or MRI safety information is provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954465 | Date9 Nov 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0658-2016
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
-
- Terminated Z-0192-2014
Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
Specification
- 510(k) Number
- FDA Product Code
- HRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Future Medical Systems, Inc.
Questions
What types of orthopedic procedures is the FMS DUO designed to assist with, and how does it improve surgical efficiency?
The FMS DUO is specifically designed for arthroscopic procedures in orthopedic surgery. It combines irrigation and fluid management with an integrated shaver system to maintain consistent fluid pressure and flow, which enhances visualization and reduces turbulence during surgery. This integration helps streamline workflow by reducing the need for separate devices, ultimately improving efficiency and precision in procedures like joint repairs or cartilage smoothing.
Is the FMS DUO intended for single-use or reusable applications, and what does this mean for maintenance and cost?
The FMS DUO is supplied as a reusable medical instrument, meaning it is built for repeated use in clinical settings after proper cleaning, disinfection, and sterilization. This design choice can reduce per-procedure costs compared to single-use devices, though it requires adherence to facility protocols for reprocessing and maintenance to ensure safety and performance consistency.
Are there specific storage requirements for the FMS DUO, and how should it be handled between uses?
The provided data does not specify storage conditions for the FMS DUO, but as a reusable device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Between uses, it must undergo thorough cleaning, disinfection, and sterilization as per manufacturer guidelines and facility protocols to prevent contamination and maintain functionality.
What distinguishes the FMS DUO from other arthroscopy fluid management systems, particularly in terms of its integrated features?
The FMS DUO stands out by integrating fluid management with an arthroscopic shaver system into a single unit, unlike standalone irrigation pumps or shavers. This combination allows surgeons to control irrigation pressure and debris removal simultaneously, improving visualization and reducing clutter in the surgical field. The system’s design aims to optimize workflow by minimizing the need for additional equipment during arthroscopic procedures.