# K051136: Smith & Nephew CDS System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 1, 2005 after 58 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960082 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960082: Discography Kit, Spinal Specialties, Inc. (1996) Summary page 1.

## Most influential descendants
- K081491: Smith & Nephew CDS System (2008), 0 descendants of its own

## Indications for use
The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.

Source page: https://510kreport.com/device/K051136
Methodology: https://510kreport.com/methodology