510(k) · Cleared
Recalled · Class II · 2020NuVasive NVM5 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · PDQ Neurosurgical Nerve Locator
Cleared on Mar 27, 2015 as substantially equivalent to K141968 (Nuvasive, Inc., 2014) after a 95-day review. Its family tree reaches back 10 generations to 1984. 22 later devices descend from it. It has been recalled once.
- Decided
- Mar 27, 2015
- Review
- 95 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K842956 (1984). 61 ancestors in all. 22 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 6 generations between
- 3 generations backK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- 2 generations backK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- 1 generation backK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- This deviceK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 13 of its ownK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 7 of its ownK162313 NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 7 of its ownK162199 Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK212166 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert…Inomed Medizintechnik GmbH · 2022
- Descendant · 2 generations on · 4 of its ownK162647 NuVasive NuvaLine Mobile AppNu Vasive, Incorporated · 2017
Show all 10 generations
- Root · 10 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 9 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 8 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 7 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 6 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 5 generations backK061113 OrthomonAxon Systems, Inc. · 2006
- 4 generations backK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- 3 generations backK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- 2 generations backK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- 1 generation backK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- This deviceK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K152942NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016 · cites it directly13descendants
- K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017 · 2 generations on7descendants
- K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. · 2017 · cites it directly7descendants
- K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH · 2022 · 2 generations on5descendants
- K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −9 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −8 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −7 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −6 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −5 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| −4 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| −3 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| −2 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| −1 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| 0 (this device) | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | — |
| +1 | K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016 | — |
| +2 | K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | 2017 | — |
| +1 | K162199 | Cascade IOMAX Intraoperative Monitor | Cadwell Industries, Inc. | 2017 | 3 |
| +2 | K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022 | — |
| +2 | K162647 | NuVasive NuvaLine Mobile App | Nu Vasive, Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 PDQ? 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 PDQ device
- #1 K243636 Neuralytix iD3 System (NTX-9001)score 16.5 · 14 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 |
|---|---|---|---|
| * | K141968 | Nuvasive NVM5 SystemSummary page 4…, ETN, GWF, HAW, IKN, OLO C. Predicate Devices The subject NuVasive NVM5 System is substantially equivalent to the predicate NuVasive NVM5 System - 510(k) - K141968. D. Device Description The NVM5 System is a medical device that is intended for intraoperative neurophysiologic moni… | 2014 |
What descends from it? (22)
See all 222 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2020 | Class II | Z-2684-2020 | Under Investigation by firm | The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP harness instead of the the correct part number 1747065, NVM5 Harness, Gen 3.5… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 61 ancestors have a recall of any class.
- Of its descendants, K152942 (Nu Vasive, Incorporated, 2016) has gone furthest, with 13 descendants of its own.
How does its category compare?
All PDQ devicesPDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PDQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDQ
182in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDQ
No recall names PDQ since 2007.
Adverse event reports per year · PDQ
2in 2025
MAUDE reports naming product code PDQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 5 | 181 | 0 | 1 |
| 2014 | 7 | 254 | 0 | 0 |
| 2015 | 3 | 95 | 0 | 1 |
| 2016 | 3 | 100 | 0 | 4 |
| 2017 | 2 | — | 0 | 5 |
| 2018 | 4 | 162 | 0 | 5 |
| 2019 | 4 | 182 | 0 | 10 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 2 | — | 0 | 10 |
| 2022 | 2 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The NVMS® 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. NVMS provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial or lumbar motor evoked potential (MEP), or somatosensory…
Read the full statement (446 words)
The NVMS® 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. NVMS provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial or lumbar motor evoked potential (MEP), or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.
* 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.
* MEP — Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP 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.
» 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 NVMS System for a monitoring physician outside of the operating room.
» Guidance — The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar and sacral spine (L1-S1) 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.
* Bendini — The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
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/K143641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143641: 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/K143641
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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