# K171794: Smith & Nephew 25 Fluid Management System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 27, 2017 after 11 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: 8 generations back to K950035 (1996). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051326: Smith & Nephew 25 Fluid Management System, Smith & Nephew, Inc. (2005) Summary page 4.

## Indications for use
The Smith & Nephew DYONICS 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip, and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site,

Source page: https://510kreport.com/device/K171794
Methodology: https://510kreport.com/methodology