510(k) · Cleared
Recalled · Class III · 2016Stryker RF Multi-Lesion Generator, Model 0406-900-000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synergetics, Inc. · GXD Generator, Lesion, Radiofrequency
Cleared on Dec 20, 2007 as substantially equivalent to K032601 (Valley Forge Scientific Corp., 2004) and 1 other predicate after a 204-day review. Its family tree reaches back 1 generation to 2004. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 20, 2007
- Review
- 204 days
- Class
- Class II
- Product code
- GXD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K032601 (2004). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK032601 Stryker Interventional Pain RF GeneratorValley Forge Scientific Corp. · 2004 · Recalled
- This deviceK071482 Stryker RF Multi-Lesion Generator, Model 0406-900-000Synergetics, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK111576 NT 2000 Lesioning GeneratorNeuro Therm, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK232632 Racz Neurostat RF GeneratorEpimed International · 2024
- Descendant · 2 generations on · 0 of its ownK220122 APEX 6Rf Innovations, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK201610 IonicRF GeneratorAbbott Medical · 2020
- Descendant · cites it directly · 0 of its ownK170242 MultiGen™ 2 RF Generator SystemStryker Corporation · 2017
Most influential descendants
Showing 5 of 5 · See all- K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc. · 2011 · cites it directly3descendants
- K232632Racz Neurostat RF GeneratorEpimed International · 2024 · 2 generations on0descendants
- K220122APEX 6Rf Innovations, Inc. · 2023 · 2 generations on0descendants
- K201610IonicRF GeneratorAbbott Medical · 2020 · 2 generations on0descendants
- K170242MultiGen™ 2 RF Generator SystemStryker Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032601 | Stryker Interventional Pain RF Generator | Valley Forge Scientific Corp. | 2004 | 1 |
| 0 (this device) | K071482 | Stryker RF Multi-Lesion Generator, Model 0406-900-000 | Synergetics, Inc. | 2007 | — |
| +1 | K111576 | NT 2000 Lesioning Generator | Neuro Therm, Inc. | 2011 | 4 |
| +2 | K232632 | Racz Neurostat RF Generator | Epimed International | 2024 | — |
| +2 | K220122 | APEX 6 | Rf Innovations, Inc. | 2023 | — |
| +2 | K201610 | IonicRF Generator | Abbott Medical | 2020 | — |
| +1 | K170242 | MultiGen™ 2 RF Generator System | Stryker Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 | Decided |
|---|---|---|---|
| * | K032601 | Stryker Interventional Pain RF GeneratorSummary page 1…Multi-lesion Generator Common Name: Radiofirequency Lesion Generator Classification Name: Generator, Radiofirequency Lesion (GXD) Equivalent to: K032601 Stryker Interventional Pain RE Generator K052878 Neurotherm NT 1000 RE Lesioning System Device Descriptio… | 2004 |
| * | K052878 | NT-1000Summary page 1…enerator Classification Name: Generator, Radiofirequency Lesion (GXD) Equivalent to: K032601 Stryker Interventional Pain RE Generator K052878 Neurotherm NT 1000 RE Lesioning System Device Description: Stryker RF Multi-lesion Generator The Stry… | 2006 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2016 | Class III | Z-0584-2017 | Labeling Change Control | Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator, because the instructions for use incorrectly contained instructions supporting the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Stiyker RE Multi-Lesion Generator, in combination with the Stryker RF Electrodes and Cannulae are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Exmnples include, but are not limited to: Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.
The Sthyker RE Muli-Lesion Generator in combination with a Smith & Nephew SPINECATiTM &Acuthe'mnTM catheters are intended for coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071482: Stryker RF Multi-Lesion Generator, Model 0406-900-000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071482
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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