510(k) · Cleared
ClearedStryker Venom Electrodes and Cannulae
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments, Instruments Div. · GXI Probe, Radiofrequency Lesion
Cleared on Mar 28, 2013 as substantially equivalent to K032406 (Stryker Instruments, 2004) and 2 other predicates after a 170-day review. Its family tree reaches back 8 generations to 1987. 2 later devices descend from it.
- Decided
- Mar 28, 2013
- Review
- 170 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K870028 (1987). 16 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 7 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 6 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 5 generations backK021942 Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 2002
- 4 generations backK042375 SMK, CX, Cxe, RCNTechnomed Europe · 2004
- 3 generations backK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
- 2 generations backK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
- 1 generation backK082012 Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
- This deviceK123178 Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div. · 2013
- Descendant · cites it directly · 0 of its ownK191293 LCCS VC-S RF CannulaLccs Products Limited · 2020
- Descendant · cites it directly · 0 of its ownK170242 MultiGen™ 2 RF Generator SystemStryker Corporation · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −7 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −6 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −5 | K021942 | Radionics Pole Needles | Radionics, A Division of Tyco Healthcare Group LP | 2002 | — |
| −4 | K042375 | SMK, CX, Cxe, RCN | Technomed Europe | 2004 | — |
| −3 | K053415 | Lesionpoint RF Cannula | Cosman Medical, Inc. | 2006 | — |
| −2 | K060799 | Cosman CSK RF Cannula; Cosman RFK RF Cannula | Cosman Medical, Inc. | 2006 | — |
| −1 | K082012 | Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CN | Cosman Medical, Inc. | 2008 | — |
| 0 (this device) | K123178 | Stryker Venom Electrodes and Cannulae | Stryker Instruments, Instruments Div. | 2013 | — |
| +1 | K191293 | LCCS VC-S RF Cannula | Lccs Products Limited | 2020 | — |
| +1 | K170242 | MultiGen™ 2 RF Generator System | Stryker Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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? (3)
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 | Decided |
|---|---|---|---|
| * | K032406 | Stryker RF Electrodes and CannulaeSummary page 1…ion Name: probe, radiofrequency lesion; GXI 3. Legally Marketed Predicate Device(s) 5 10(k) Number Product Code Trade Name Manufacturer K032406 GXI Strykerg) Monopolar Stryker Instruments Electrodes… | 2004 |
| * | K082012 | Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNSummary page 2…son Stryker® VdnomTM Stryker@ Monopolar Cosman REF Comparison Electrodes and Electrodes and Electrodes (K082012) Cannulae Cannulae (K032406) and Cannulac… | 2008 |
| * | K060799 | Cosman CSK RF Cannula; Cosman RFK RF CannulaSummary page 1…Manufacturer K032406 GXI Strykerg) Monopolar Stryker Instruments Electrodes and Cannulae K060799 GXI Cosman REF Cannula Cosman Medical, Inc. 4. Device Description The Stryker Cannulae w… | 2006 |
What descends from it? (2)
2 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)
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 26 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K191293 (Lccs Products Limited, 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K032406.
How does its category compare?
All GXI devicesGXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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/Multigen, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. These products are also used for selective dlenervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerves, and nerve roots for the relief of pain. Examples include, but are not limited to, Facette Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123178: Stryker Venom Electrodes and Cannulae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123178
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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