# K171237: FMS VUE II Fluid Management and Tissue Debridement System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jan 18, 2018 after 266 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954465 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130169: FMS Vue Fluid Managment System, FMS Connect Interface Cable, Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 4.

## Indications for use
The FMS VUE II Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.

Source page: https://510kreport.com/device/K171237
Methodology: https://510kreport.com/methodology