510(k) · Cleared
Recalled · Class II · 2024Stryker RF Electrodes and Cannulae
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · GXI Probe, Radiofrequency Lesion
Cleared on Apr 1, 2004 after a 241-day review. The FDA summary names no predicate by number. 22 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 1, 2004
- Review
- 241 days
- Class
- Class II
- Product code
- GXI
- Recalls
- 3
- Predicates
- 0
22 later devices descend from it, 4 citing it directly.
- This deviceK032406 Stryker RF Electrodes and CannulaeStryker Instruments · 2004
- Descendant · cites it directly · 17 of its ownK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
- Descendant · 2 generations on · 7 of its ownK153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016
- Descendant · 2 generations on · 5 of its ownK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
- Descendant · 3 generations on · 4 of its ownK180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF…Relievant Medsystems · 2018
- Descendant · 3 generations on · 4 of its ownK170827 INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K043442Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005 · cites it directly17descendants
- K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016 · 2 generations on7descendants
- K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006 · 2 generations on5descendants
- K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems · 2018 · 3 generations on4descendants
- K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032406 | Stryker RF Electrodes and Cannulae | Stryker Instruments | 2004 | — |
| +1 | K043442 | Stryker RF Coaxial Bipolar Electrodes & Cannulae | Stryker Instruments | 2005 | — |
| +2 | K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | Relievant Medsystems | 2016 | — |
| +2 | K061660 | Stryker RF Parallel Bipolar Adaptor Cable | Stryker Instruments | 2006 | — |
| +3 | K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Relievant Medsystems | 2018 | — |
| +3 | K170827 | INTRACEPT Intraosseous Nerve Ablation System | Relievant Medsystems | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (22)
See all 224 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2024 | Class II | Z-2261-2024 | Storage | Expired Products distributed to customers |
| Jul 17, 2012 | Class II | Z-2134-2012 | Labeling mix-ups | Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the… |
| Jul 17, 2012 | Class II | Z-2135-2012 | Labeling mix-ups | Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K043442 (Stryker Instruments, 2005) has gone furthest, with 17 descendants of its own.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXI
183in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXI
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXI
98in 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, arthroscopic, 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/K032406 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032406: Stryker RF Electrodes and Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032406
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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