510(k) · Cleared
ClearedMultiGen™ 2 RF Generator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · GXD Generator, Lesion, Radiofrequency
Cleared on May 25, 2017 as substantially equivalent to K071482 (Synergetics, Inc., 2007) and 2 other predicates after a 119-day review. Its family tree reaches back 9 generations to 1987.
- Decided
- May 25, 2017
- Review
- 119 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K870028 (1987). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 5 generations between
- 3 generations backK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
- 2 generations backK082012 Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
- 1 generation backK123178 Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div. · 2013
- This deviceK170242 MultiGen™ 2 RF Generator SystemStryker Corporation · 2017
Show all 9 generations
- Root · 9 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 8 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 7 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 6 generations backK021942 Radionics Pole NeedlesRadionics, A Division of Tyco Healthcare Group LP · 2002
- 5 generations backK042375 SMK, CX, Cxe, RCNTechnomed Europe · 2004
- 4 generations backK053415 Lesionpoint RF CannulaCosman Medical, Inc. · 2006
- 3 generations backK060799 Cosman CSK RF Cannula; Cosman RFK RF CannulaCosman Medical, Inc. · 2006
- 2 generations backK082012 Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CNCosman Medical, Inc. · 2008
- 1 generation backK123178 Stryker Venom Electrodes and CannulaeStryker Instruments, Instruments Div. · 2013
- This deviceK170242 MultiGen™ 2 RF Generator SystemStryker Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −8 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −7 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −6 | K021942 | Radionics Pole Needles | Radionics, A Division of Tyco Healthcare Group LP | 2002 | — |
| −5 | K042375 | SMK, CX, Cxe, RCN | Technomed Europe | 2004 | — |
| −4 | K053415 | Lesionpoint RF Cannula | Cosman Medical, Inc. | 2006 | — |
| −3 | K060799 | Cosman CSK RF Cannula; Cosman RFK RF Cannula | Cosman Medical, Inc. | 2006 | — |
| −2 | K082012 | Cosman RF Injection Electrodes, Models CU, Cur, CCD, TCD, CP, CR, CN | Cosman Medical, Inc. | 2008 | — |
| −1 | K123178 | Stryker Venom Electrodes and Cannulae | Stryker Instruments, Instruments Div. | 2013 | — |
| 0 (this device) | 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 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 GXD? 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 GXD device
- #1 K251247 GX1 Radiofrequency Generator Kit…score 11.0 · 5 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 |
|---|---|---|---|
| * | K071482 | Stryker RF Multi-Lesion Generator, Model 0406-900-000Summary page 7…882.4400 / 882.4725 Panel: Neurology Product Code: GXD / GXI Predicate Devices The following devices are predicates for the system: Stryker RF Multi-lesion Generator (K071482) Stryker RF Electrodes and Cannulae (K032406) Stryker Venom Electrodes and Cannulae (K123178) The following reference device was… | 2007 |
| * | K032406 | Stryker RF Electrodes and CannulaeSummary page 7…Code: GXD / GXI Predicate Devices The following devices are predicates for the system: Stryker RF Multi-lesion Generator (K071482) Stryker RF Electrodes and Cannulae (K032406) Stryker Venom Electrodes and Cannulae (K123178) The following reference device was used in this submission: Stryker Interventio… | 2004 |
| * | K123178 | Stryker Venom Electrodes and CannulaeSummary page 7…ng devices are predicates for the system: Stryker RF Multi-lesion Generator (K071482) Stryker RF Electrodes and Cannulae (K032406) Stryker Venom Electrodes and Cannulae (K123178) The following reference device was used in this submission: Stryker Interventional Pain RF Generator (K032601) Device Descrip… | 2013 |
| † | K032601 | Stryker Interventional Pain RF Generator | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 20 ancestors have a recall of any class.
- 1 other device also cites its predicate K071482.
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GXD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXD
185in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXD
88in 2025
MAUDE reports naming product code GXD, 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 | 185 | 0 | 10 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 1 | — | 1 | 69 |
| 2011 | 2 | — | 0 | 89 |
| 2012 | 0 | — | 0 | 77 |
| 2013 | 0 | — | 0 | 119 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 0 | 67 |
| 2016 | 0 | — | 1 | 51 |
| 2017 | 2 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 156 |
| 2019 | 1 | — | 1 | 195 |
| 2020 | 2 | — | 0 | 138 |
| 2021 | 0 | — | 0 | 154 |
| 2022 | 1 | — | 0 | 84 |
| 2023 | 2 | — | 1 | 54 |
| 2024 | 2 | — | 0 | 63 |
| 2025 | 1 | — | 0 | 88 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Stryker MultiGen™ 2 RF Generator The Stryker MultiGen™ 2 RF Generator, in combination with the Stryker MultiGen 2 Electrodes and RF Cannulae, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy. Venom MultiGen 2 Electrodes The Stryker Venom MultiGen 2 Electrodes, in combination with the…
Read the full statement (311 words)
Stryker MultiGen™ 2 RF Generator
The Stryker MultiGen™ 2 RF Generator, in combination with the Stryker MultiGen 2 Electrodes and RF Cannulae, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.
Venom MultiGen 2 Electrodes
The Stryker Venom MultiGen 2 Electrodes, in combination with the Stryker RF Cannulae and Stryker MultiGen™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain.
Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.
Standard MultiGen 2 Standard Electrodes
The Stryker MultiGen 2 Electrodes, in combination with the Stryker RF Cannulae and Stryker MultiGen™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain.
Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.
Venom and Standard Cannulae (RF Cannulae)
The Stryker RF Cannulae, in combination with Stryker Electrodes and the Stryker RF Generator, Stryker MultiGen, or Stryker MultiGen™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. They are also used for selective denervation and destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain.
Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170242: MultiGen™ 2 RF Generator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170242
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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