510(k) · Cleared
ClearedNuvasive NVM5 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 Mar 16, 2012 as substantially equivalent to K962455 (Cadwell Laboratories, Inc., 1997) and 5 other predicates after a 179-day review. Its family tree reaches back 6 generations to 1984. 35 later devices descend from it.
- Decided
- Mar 16, 2012
- Review
- 179 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K842956 (1984). 44 ancestors in all. 35 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 5 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 4 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 3 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 2 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 1 generation backK061113 OrthomonAxon Systems, Inc. · 2006
- This deviceK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- Descendant · cites it directly · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- Descendant · 2 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- Descendant · 3 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- Descendant · 4 generations on · 22 of its ownK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- Descendant · 5 generations on · 13 of its ownK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · cites it directly33descendants
- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 2 generations on24descendants
- K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 3 generations on23descendants
- K143641NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · 4 generations on22descendants
- K152942NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −5 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −4 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −3 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −2 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −1 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| 0 (this device) | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| +1 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| +2 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| +3 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| +4 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
| +5 | K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K962455 | Four-Channel PreamplifierSummary page 1…one or more of the following predicate devices listed in Table 1 below. 510(k) . -Trade or proprietaryor~ model name Manufacturer K962455 Cadwell Cascade Cadwell Laboratories, Inc. K05 1357 DS7A Constant Cur… | 1997 |
| * | K051357 | DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High…Summary page 1…rade or proprietaryor~ model name Manufacturer K962455 Cadwell Cascade Cadwell Laboratories, Inc. K05 1357 DS7A Constant Current High Voltage Stimulator Digitimer LTD K06 1113 NIM Eclipse and probes (formerl… | 2005 |
| * | K061113 | OrthomonSummary page 1…well Cascade Cadwell Laboratories, Inc. K05 1357 DS7A Constant Current High Voltage Stimulator Digitimer LTD K06 1113 NIM Eclipse and probes (formerly Axon Systems Medtronic Xomed, Inc. OrthoMon System) K… | 2006 |
| * | K050438 | Stealthstation System UpdateSummary page 1…mulator Digitimer LTD K06 1113 NIM Eclipse and probes (formerly Axon Systems Medtronic Xomed, Inc. OrthoMon System) K050438 StealthStation® System Medtronic Inc. K061 148 Disc Electrodes… | 2005 |
| * | K061148 | Rhythmlink Disc ElectrodesSummary page 1…ystems Medtronic Xomed, Inc. OrthoMon System) K050438 StealthStation® System Medtronic Inc. K061 148 Disc Electrodes R-hythmlink International, LLC K022914 Subdermal Need… | 2006 |
| * | K022914 | Rhythmlink International Subdermal Needle ElectrodesSummary page 1…tation® System Medtronic Inc. K061 148 Disc Electrodes R-hythmlink International, LLC K022914 Subdermal Needle Electrodes Rhythmlink International, LLC D. Device Description N VM5®… | 2002 |
What descends from it? (35)
See all 354 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 28 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 5 of the 44 ancestors have a recall of any class.
- Of its descendants, K123307 (Nuvasive, Inc., 2013) has gone furthest, with 33 descendants of its own.
- 1 other device also cites its predicate K962455.
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 NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5® provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TcMEP) or somatosensory evoked…
Read the full statement (353 words)
The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5® provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TcMEP) or somatosensory evoked potential (SSEP) responses of nerves.
* XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.
* 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 motor pathway integrity during procedures with a risk of surgically induced motor injury.
* SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.
* Remote Reader - The Remote Reader function provides real time remote access to the NVM5 System for a monitoring physician outside of the operating room.
* The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar spine of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the angulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.
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/K112718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112718: Nuvasive NVM5 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112718
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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