510(k) · Cleared
ClearedStryker Intradiscal RF Generator
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 May 23, 2007 as substantially equivalent to K033981 (Smith & Nephew, Inc., 2004) after a 187-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- May 23, 2007
- Review
- 187 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K896183 (1990). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK896183 KTP/532 Surgical Laser for Percutaneous DiskectomyLaserscope · 1990
- 3 generations backK974464 Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998
- 2 generations backK993854 Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc. · 1999
- 1 generation backK033981 Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Smith & Nephew, Inc. · 2004
- This deviceK063489 Stryker Intradiscal RF GeneratorSynergetics, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896183 | KTP/532 Surgical Laser for Percutaneous Diskectomy | Laserscope | 1990 | — |
| −3 | K974464 | Oratec Spinecath Intradiscal Catheter | Oratec Interventions, Inc. | 1998 | — |
| −2 | K993854 | Ora-50 S Autotemp Electrothermal Spine System and Accessories | Oratec Interventions, Inc. | 1999 | — |
| −1 | K033981 | Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975 | Smith & Nephew, Inc. | 2004 | — |
| 0 (this device) | K063489 | Stryker Intradiscal RF Generator | Synergetics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K033981 | Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975Summary page 1…ntradiscal RF Generator Common Name: Radiofrequency Lesion Generator Classification Name: Generator, Radiofrequency Lesion (GXD) Equivalent to: K033981 Smith & Nephew ElectroThermal 20S Spine Generator Device Description: The Stryker Intra… | 2004 |
| † | K993967 | Oratec Spinecath Intradiscal Catheter, Model 920002 | 1999 |
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 17 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 9 ancestors has a recall.
- 3 other devices also cite its predicate K033981.
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 Stryker Intradiscal RF Generator is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Stryker Intradiscal RF Generator will be used with the previously cleared Stryker RF Intradiscal Adapter and catheters such as Smith & Nephew Spinecath TM & Acutherm TM catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063489: Stryker Intradiscal RF Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063489
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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