510(k) · Cleared
ClearedStimulation/Dissection Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · ETN Stimulator, Nerve
Cleared on Feb 9, 2012 as substantially equivalent to K031003 (Medtronic Xomed, Inc., 2003) and 1 other predicate after a 143-day review. Its family tree reaches back 7 generations to 1992. 9 later devices descend from it.
- Decided
- Feb 9, 2012
- Review
- 143 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K923056 (1992). 15 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
- 6 generations backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- 5 generations backK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
- 4 generations backK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
- 3 generations backK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
- 2 generations backK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
- 1 generation backK111597 Disposable Stimulating ElectrodeNuvasive, Inc. · 2011
- This deviceK112709 Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012
- Descendant · cites it directly · 5 of its ownK132373 Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014
- Descendant · 2 generations on · 4 of its ownK142438 Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015
- Descendant · 3 generations on · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 4 generations on · 2 of its ownK191723 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 5 generations on · 1 of its ownK221821 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014 · cites it directly5descendants
- K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · 2015 · 2 generations on4descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 3 generations on3descendants
- K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 4 generations on2descendants
- K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | 1 |
| −6 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| −5 | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… | Technomed Europe | 2005 | — |
| −4 | K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | 2007 | — |
| −3 | K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | 2007 | — |
| −2 | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… | Cadwell Lab, Inc. | 2011 | — |
| −1 | K111597 | Disposable Stimulating Electrode | Nuvasive, Inc. | 2011 | — |
| 0 (this device) | K112709 | Stimulation/Dissection Instruments | Nu Vasive, Incorporated | 2012 | — |
| +1 | K132373 | Biomet Access System | Biomet Spine (Aka Ebi, LLC) | 2014 | — |
| +2 | K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015 | — |
| +3 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +4 | K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +5 | K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 ETN? 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 ETN device
- #1 K251672 NIM Essence™ EMG Endotracheal Tube…score 12.3 · 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 |
|---|---|---|---|
| * | K031003 | Stimulus/Dissection Instruments, Ball-Tip ProbesSummary page 1…ubject Stimulation/Dissection Instruments are substantially equivalent to the following predicate devices currently distributed commercially in the U.S.: " K03 1003 - Medtronic Stimulation/Dissection Instruments " KI 11597 - NuVasive Disposable Stimulating Electrode D. Device Descr… | 2003 |
| * | K111597 | Disposable Stimulating Electrode Cleared while this submission was under review | 2011 |
What descends from it? (9)
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 20 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K132373 (Biomet Spine (Aka Ebi, LLC), 2014) has gone furthest, with 5 descendants of its own.
- 8 other devices also cite its predicate K031003.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ETN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETN
98in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ETN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETN
1,145in 2025
MAUDE reports naming product code ETN, 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 | 2 | — | 0 | 5 |
| 2008 | 2 | — | 1 | 5 |
| 2009 | 5 | 115 | 0 | 22 |
| 2010 | 3 | 168 | 1 | 26 |
| 2011 | 9 | 115 | 0 | 55 |
| 2012 | 7 | 179 | 0 | 187 |
| 2013 | 1 | — | 0 | 270 |
| 2014 | 2 | — | 0 | 137 |
| 2015 | 1 | — | 0 | 202 |
| 2016 | 2 | — | 1 | 145 |
| 2017 | 0 | — | 0 | 117 |
| 2018 | 0 | — | 0 | 250 |
| 2019 | 0 | — | 2 | 314 |
| 2020 | 1 | — | 1 | 238 |
| 2021 | 1 | — | 1 | 197 |
| 2022 | 2 | — | 0 | 247 |
| 2023 | 5 | 98 | 1 | 390 |
| 2024 | 2 | — | 0 | 748 |
| 2025 | 1 | — | 0 | 1,145 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Stimulation/Dissection Instruments are indicated for tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112709: Stimulation/Dissection Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112709
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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