# K050580: Smith & Nephew Intelijet Fluid Management Systems

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Apr 20, 2005 after 44 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: 6 generations back to K950035 (1996). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002040: FMS Solo, Future Medical Systems, Inc. (2000) Summary page 1.
- K033927: Arthoscopy Pump A115, W.O.M. World of Medicine AG (2004) Summary page 1.
- K041824: X-Treme Arthroscopic Pump and Shaver System, Future Medical Systems, SA (2005) Summary page 1.

## Most influential descendants
- K051326: Smith & Nephew 25 Fluid Management System (2005), 1 descendant of its own
- K171794: Smith & Nephew 25 Fluid Management System (2017), 0 descendants of its own

## Indications for use
The Smith & Nephew InteliJETTM 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. The Smith & Nephew InteliJET M Fluid Management System-HERMES Ready 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/K050580
Methodology: https://510kreport.com/methodology