510(k) · Cleared

Cleared

Stryker RF Coaxial Bipolar Electrodes & Cannulae

K043442510(k) TraditionalCleared May 31, 2005168-day reviewClass II21 CFR 882.4725

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

Stryker Instruments · GXI Probe, Radiofrequency Lesion

Cleared on May 31, 2005 as substantially equivalent to K032406 (Stryker Instruments, 2004) and 4 other predicates after a 168-day review. Its family tree reaches back 2 generations to 1999. 17 later devices descend from it.

Decided: May 31, 2005
Review: 168 days
Class: Class II
Product code: GXI
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K991218 (1999). 8 ancestors in all, the oldest K896450 (1991). 17 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK991218 Oratec Bipolar Ablation ProbesOratec Interventions, Inc. · 1999
1 generation backK031371 Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003
This deviceK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
Descendant · cites it directly · 7 of its ownK153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016
Descendant · cites it directly · 5 of its ownK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
Descendant · 2 generations on · 4 of its ownK180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF…Relievant Medsystems · 2018
Descendant · 2 generations on · 4 of its ownK170827 INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017
Descendant · 2 generations on · 4 of its ownK083528 Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2006high 2 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 17 · See all

K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016 · cites it directly7descendants
K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006 · cites it directly5descendants
K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems · 2018 · 2 generations on4descendants
K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017 · 2 generations on4descendants
K083528Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K991218	Oratec Bipolar Ablation Probes	Oratec Interventions, Inc.	1999	—
−1	K031371	Saphyre Bipolar Ablation Probes	Smith & Nephew, Inc.	2003	—
0 (this device)	K043442	Stryker RF Coaxial Bipolar Electrodes & Cannulae	Stryker Instruments	2005	—
+1	K153272	INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set	Relievant Medsystems	2016	—
+1	K061660	Stryker RF Parallel Bipolar Adaptor Cable	Stryker Instruments	2006	—
+2	K180369	Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)	Relievant Medsystems	2018	—
+2	K170827	INTRACEPT Intraosseous Nerve Ablation System	Relievant Medsystems	2017	—
+2	K083528	Smith & Nephew Bipolar Adapter Cable, Model 72200022	Smith & Nephew, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
2000	2	0
2001	1	0
2004	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	1	0
2009	2	0
2012	1	0
2014	1	0
2015	1	0
2016	1	0
2017	1	0
2018	1	0
2019	1	0
2022	2	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K043442, 1999–2026Source: 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 GXI? 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 GXI device

#1 K253907 Disposable Radiofrequency Cannulascore 12.7 · 6 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? (5)

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
*	K032406	Stryker RF Electrodes and Cannulae Summary page 1 …21CFR882.4725 Product Code: GXI Predicate Devices: Stryker RF Electrodes and Cannulae - K032406 Stryker Interventional Pain RF Generator - K032601 Stryker Instruments Neuro N50 - K896450…	Stryker Instruments	2004	3
*	K032601	Stryker Interventional Pain RF Generator Summary page 1 …Product Code: GXI Predicate Devices: Stryker RF Electrodes and Cannulae - K032406 Stryker Interventional Pain RF Generator - K032601 Stryker Instruments Neuro N50 - K896450 Bayliss Pain Management Probe - K002389…	Valley Forge Scientific Corp.	2004	1
*	K896450	Neuro N 50 Lesion Generator Summary page 1 …es: Stryker RF Electrodes and Cannulae - K032406 Stryker Interventional Pain RF Generator - K032601 Stryker Instruments Neuro N50 - K896450 Bayliss Pain Management Probe - K002389 Smith and Nephew Saphyre Bipolar Ablation Probes -…	Leibinger & Fischer, Ltd.	1991	—
*	K002389	Baylis Pain Management Probe/PMP-20-145 and Baylis Pain Management Connector… Summary page 1 …Stryker Interventional Pain RF Generator - K032601 Stryker Instruments Neuro N50 - K896450 Bayliss Pain Management Probe - K002389 Smith and Nephew Saphyre Bipolar Ablation Probes - K031 371 Description: The Stryker RF Coaxial Bipolar Elec…	Baylis Medical Co., Inc.	2000	—
*	K031371	Saphyre Bipolar Ablation Probes Summary page 1 …Stryker Instruments Neuro N50 - K896450 Bayliss Pain Management Probe - K002389 Smith and Nephew Saphyre Bipolar Ablation Probes - K031 371 Description: The Stryker RF Coaxial Bipolar Electrodes and Cannulae will be used in conjunction with the Stryker RF Generator a…	Smith & Nephew, Inc.	2003	—

Also cleared against K032406: 3 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K153272	INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set	Relievant Medsystems	2016	7
K061660	Stryker RF Parallel Bipolar Adaptor Cable	Stryker Instruments	2006	5
K070443	Intracept BI-Polar RF Probe, Model 04814	Relievant Medsystems, Inc.	2007	2

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 6 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
2 of the 8 ancestors have a recall of any class.
Of its descendants, K153272 (Relievant Medsystems, 2016) has gone furthest, with 7 descendants of its own.
3 other devices also cite its predicate K032406.

How does its category compare?

All GXI devices

GXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXI

4in 2025

2007high 4 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXI

183in 2025

2007high 255 (2020) · low 63 (2019)2026

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

Recalls per year · GXI

1in 2019

2007high 3 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXI

98in 2025

2007high 150 (2017) · low 1 (2007)2025

MAUDE reports naming product code GXI, 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	4	87	3	1
2008	2	—	1	4
2009	2	—	0	10
2010	2	—	1	8
2011	3	64	0	5
2012	1	—	1	14
2013	1	—	1	25
2014	1	—	0	20
2015	1	—	0	23
2016	3	240	0	16
2017	3	125	1	150
2018	1	—	0	147
2019	3	63	1	93
2020	3	255	0	31
2021	0	—	0	30
2022	2	—	0	46
2023	0	—	0	35
2024	0	—	0	45
2025	4	183	0	98
2026	2	—	3	—

What is it indicated for?

The Stryker RF Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications.

They are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the spinal cord, peripheral nerves, and nerve roots for the relief of pain. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043442 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043442: Stryker RF Coaxial Bipolar Electrodes & Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043442

Report an extraction error

Are you the manufacturer?

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