510(k) · Cleared
ClearedINTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Relievant Medsystems · GXI Probe, Radiofrequency Lesion
Cleared on Jul 9, 2016 as substantially equivalent to K100641 (Relievant Medsystems, 2010) and 1 other predicate after a 240-day review. Its family tree reaches back 3 generations to 1999. 7 later devices descend from it.
- Decided
- Jul 9, 2016
- Review
- 240 days
- Class
- Class II
- Product code
- GXI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K991218 (1999). 10 ancestors in all, the oldest K896450 (1991). 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK991218 Oratec Bipolar Ablation ProbesOratec Interventions, Inc. · 1999
- 2 generations backK031371 Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003
- 1 generation backK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
- This deviceK153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016
- Descendant · cites it directly · 4 of its ownK180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF…Relievant Medsystems · 2018
- Descendant · cites it directly · 4 of its ownK170827 INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017
- Descendant · 2 generations on · 3 of its ownK190504 Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept…Relievant Medsystems · 2019
- Descendant · 3 generations on · 1 of its ownK213836 Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK251802 STAR RF Ablation SystemMerit Medical Systems, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems · 2018 · cites it directly4descendants
- K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017 · cites it directly4descendants
- K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve…Relievant Medsystems · 2019 · 2 generations on3descendants
- K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022 · 3 generations on1descendant
- K251802STAR RF Ablation SystemMerit Medical Systems, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991218 | Oratec Bipolar Ablation Probes | Oratec Interventions, Inc. | 1999 | — |
| −2 | K031371 | Saphyre Bipolar Ablation Probes | Smith & Nephew, Inc. | 2003 | — |
| −1 | K043442 | Stryker RF Coaxial Bipolar Electrodes & Cannulae | Stryker Instruments | 2005 | — |
| 0 (this device) | K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | Relievant Medsystems | 2016 | — |
| +1 | K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | Relievant Medsystems | 2018 | — |
| +1 | K170827 | INTRACEPT Intraosseous Nerve Ablation System | Relievant Medsystems | 2017 | — |
| +2 | K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept… | Relievant Medsystems | 2019 | — |
| +3 | K213836 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022 | — |
| +1 | K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 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? (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 |
|---|---|---|---|
| * | K100641 | Intracept Flexible BI-Polar RF Probe and Easy Access Instrument Set, Model FG0018…Summary page 4…Nerve Ablation System is substantially equivalent to the following legally marketed devices: Intracept Easy Access Instrument Set and Flexible Bi-Polar RF Probe (K100641) Stryker RF Coaxial Bipolar Electrodes and Cannulae (K043442) Device Description: The Intracept System is comprised of tw… | 2010 |
| * | K043442 | Stryker RF Coaxial Bipolar Electrodes & CannulaeSummary page 4…egally marketed devices: Intracept Easy Access Instrument Set and Flexible Bi-Polar RF Probe (K100641) Stryker RF Coaxial Bipolar Electrodes and Cannulae (K043442) Device Description: The Intracept System is comprised of two basic, sterile, single use components, both of which are currently… | 2005 |
What descends from it? (7)
3 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 17 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K180369 (Relievant Medsystems, 2018) has gone furthest, with 4 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. 2016, 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 Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153272: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153272
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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