510(k) · Cleared

Cleared

Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975

K033981510(k) TraditionalCleared Feb 25, 200464-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 25, 2004 as substantially equivalent to K993854 (Oratec Interventions, Inc., 1999) and 1 other predicate after a 64-day review. Its family tree reaches back 3 generations to 1990. 14 later devices descend from it.

Decided: Feb 25, 2004
Review: 64 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K896183 (1990). 8 ancestors in all. 14 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK896183 KTP/532 Surgical Laser for Percutaneous DiskectomyLaserscope · 1990
2 generations backK974464 Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998
1 generation backK993854 Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc. · 1999
This deviceK033981 Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc. · 2004
Descendant · cites it directly · 11 of its ownK130689 Symphony RF GeneratorThermigen, Inc. · 2013
Descendant · 2 generations on · 6 of its ownK171094 Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017
Descendant · 3 generations on · 3 of its ownK222260 Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400…Capenergy Medical S.L. · 2023
Descendant · cites it directly · 3 of its ownK161661 Thermi RF AccessoriesThermi · 2016
Descendant · 2 generations on · 2 of its ownK170116 Thermi Injectable RF ElectrodesThermi · 2017

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2007high 3 (2016) · low 0 (2008)2026

Most influential descendants

Showing 5 of 14 · See all

K130689Symphony RF GeneratorThermigen, Inc. · 2013 · cites it directly11descendants
K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C · 2017 · 2 generations on6descendants
K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L. · 2023 · 3 generations on3descendants
K161661Thermi RF AccessoriesThermi · 2016 · cites it directly3descendants
K170116Thermi Injectable RF ElectrodesThermi · 2017 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K896183	KTP/532 Surgical Laser for Percutaneous Diskectomy	Laserscope	1990	—
−2	K974464	Oratec Spinecath Intradiscal Catheter	Oratec Interventions, Inc.	1998	—
−1	K993854	Ora-50 S Autotemp Electrothermal Spine System and Accessories	Oratec Interventions, Inc.	1999	—
0 (this device)	K033981	Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975	Smith & Nephew, Inc.	2004	—
+1	K130689	Symphony RF Generator	Thermigen, Inc.	2013	—
+2	K171094	Thermi Reusable Non-invasive RF Electrode	Thermgen, L.L.C	2017	—
+3	K222260	Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500	Capenergy Medical S.L.	2023	—
+1	K161661	Thermi RF Accessories	Thermi	2016	—
+2	K170116	Thermi Injectable RF Electrodes	Thermi	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1994	1	0
1995	1	0
1998	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2013	1	0
2016	3	0
2017	2	0
2018	1	0
2023	2	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K033981, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K993854	Ora-50 S Autotemp Electrothermal Spine System and Accessories Summary page 1 …al Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew ORA-50 S, cleared in K993854 and Radionic's RFG-3C Plus Lesion Generator, cleared in K982489.…	Oratec Interventions, Inc.	1999	—
*	K982489	RFG-3C Plus Summary page 1 …gally marketed device in commercial distribution: Smith & Nephew ORA-50 S, cleared in K993854 and Radionic's RFG-3C Plus Lesion Generator, cleared in K982489. S &N - ET 20S Spine Generator…	Radionics, Inc.	1998	—

Also cleared against K993854: 1 other device →

What descends from it? (14)

See all 14

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130689	Symphony RF Generator	Thermigen, Inc.	2013	11
K161661	Thermi RF Accessories	Thermi	2016	3
K063489	Stryker Intradiscal RF Generator	Synergetics, Inc.	2007	0
K063480	Stryker RF Intradiscal Adaptor, Model 406-750	Stryker Corp.	2007	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K130689 (Thermigen, Inc., 2013) has gone furthest, with 11 descendants of its own.
1 other device also cites its predicate K993854.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033981 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033981: Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033981

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026