# K063489: Stryker Intradiscal RF Generator

- Pathway: 510(k) (Traditional)
- Applicant: Synergetics, Inc.
- Decided: May 23, 2007 after 187 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K896183 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033981: Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975, Smith & Nephew, Inc. (2004) Summary page 1.

## Indications for use
The Stryker Intradiscal RF Generator is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Stryker Intradiscal RF Generator will be used with the previously cleared Stryker RF Intradiscal Adapter and catheters such as Smith & Nephew Spinecath TM & Acutherm TM catheters.

Source page: https://510kreport.com/device/K063489
Methodology: https://510kreport.com/methodology