510(k) · Cleared
ClearedNuvasive Nvjjb System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive, Inc. · ETN Stimulator, Nerve
Cleared on Apr 13, 2012 as substantially equivalent to K112718 (Nuvasive, Inc., 2012) and 5 other predicates after a 207-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Apr 13, 2012
- Review
- 207 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K923056 (1992). 61 ancestors in all, the oldest K842956 (1984). No later device cites it as a predicate yet.
- Root · 8 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
- 7 generations backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
- 6 generations backK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
- 5 generations backK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
- 4 generations backK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
- 3 generations backK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
- 2 generations backK111597 Disposable Stimulating ElectrodeNuvasive, Inc. · 2011
- 1 generation backK112709 Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012
- This deviceK112717 Nuvasive Nvjjb SystemNuvasive, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K923056 | Neurosign Model 100 | The Magstim Company, Ltd. | 1992 | 1 |
| −7 | K991583 | Neurosign 400, 4 Channel Motor Nerve Monitor | The Magstim Company, Ltd. | 1999 | — |
| −6 | K050325 | Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar… | Technomed Europe | 2005 | — |
| −5 | K062996 | Disposable Monopolar and Bipolar Stimulator Probes | Axon Systems, Inc. | 2007 | — |
| −4 | K063729 | Disposable Pedicle Screw Probe, Model 3603-00 | Technomed Europe | 2007 | — |
| −3 | K103128 | Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip… | Cadwell Lab, Inc. | 2011 | — |
| −2 | K111597 | Disposable Stimulating Electrode | Nuvasive, Inc. | 2011 | — |
| −1 | K112709 | Stimulation/Dissection Instruments | Nu Vasive, Incorporated | 2012 | — |
| 0 (this device) | K112717 | Nuvasive Nvjjb System | Nuvasive, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 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? (6)
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 |
|---|---|---|---|
| * | K112718 | Nuvasive NVM5 System Cleared while this submission was under review Summary page 1…of' the following predicate devices listed in Table I below. 5 10(k) Trade or proprietary or model name Manufacturer K112718 NVM5®0 System NUVasive, Inc. K061 113 NIM Eclipse and pr… | 2012 |
| * | K061113 | OrthomonSummary page 1…de or proprietary or model name Manufacturer K112718 NVM5®0 System NUVasive, Inc. K061 113 NIM Eclipse and probes (formerly Axon Mcdtroiiic Xomed, Inc. Systems Orth… | 2006 |
| * | K051357 | DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High…Summary page 1…Inc. K061 113 NIM Eclipse and probes (formerly Axon Mcdtroiiic Xomed, Inc. Systems OrthoMon System) K05 1357 DS7A Constant Current High Voltage Stimulator Digitimner LTD K061 148 Disc Electrodes… | 2005 |
| * | K061148 | Rhythmlink Disc ElectrodesSummary page 1…c Xomed, Inc. Systems OrthoMon System) K05 1357 DS7A Constant Current High Voltage Stimulator Digitimner LTD K061 148 Disc Electrodes Rhythm link International, LLC K022914 Subd… | 2006 |
| * | K022914 | Rhythmlink International Subdermal Needle ElectrodesSummary page 1…t High Voltage Stimulator Digitimner LTD K061 148 Disc Electrodes Rhythm link International, LLC K022914 Subdermal Needle Electrodes Rhythmnlink International, LL.C KI 12709 St… | 2002 |
| * | K112709 | Stimulation/Dissection Instruments Cleared while this submission was under review | 2012 |
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 20 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 61 ancestors have a recall of any class.
- 3 other devices also cite its predicate K112718.
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 NVJJB® System is a medical device that is intended for intraoperative neurophysiological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiological status. NVJJB® provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG) or transcranial motor evoked potential…
Read the full statement (331 words)
The NVJJB® System is a medical device that is intended for intraoperative neurophysiological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiological status. NVJJB® provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG) or transcranial motor evoked potential (TcMEP) responses of nerves.
* MaXcess Detection - The MaXcess Detection function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool
* Difference Screw Test (DST) - The DST function allows the surgeon to locate and evaluate spinal nerves before, during, or after placement of bone screws by verifying nerve integrity and factoring it into the alarm criteria.
* Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
* Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
* Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
* TcMEP - Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The TcMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
* Remote Reader - The Remote Reader function provides real time remote access to the NVJJB System for a monitoring physician outside of the operating room.
* Nerve Retractor- The Nerve Retractor function allows the surgeon to locate and identify spinal nerves by directly stimulating exposed nerves to assist in identifying neurophysiological changes during retraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112717 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112717: Nuvasive Nvjjb System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112717
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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