# K033981: Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 25, 2004 after 64 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K896183 (1990). 8 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993854: Ora-50 S Autotemp Electrothermal Spine System and Accessories, Oratec Interventions, Inc. (1999) Summary page 1.
- K982489: RFG-3C Plus, Radionics, Inc. (1998) Summary page 1.

## Most influential descendants
- K130689: Symphony RF Generator (2013), 11 descendants of its own
- K171094: Thermi Reusable Non-invasive RF Electrode (2017), 6 descendants of its own
- K222260: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 (2023), 3 descendants of its own
- K161661: Thermi RF Accessories (2016), 3 descendants of its own
- K170116: Thermi Injectable RF Electrodes (2017), 2 descendants of its own

## Indications for use
The Smith & Nephew ElectroThermal® 20S Spine System is intended to create lesions in nervous tissue, and to coagulate and decompress disc material when used in combination with Smith & Nephew thermal/coagulating probes. The generator and accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K033981
Methodology: https://510kreport.com/methodology