510(k) · Cleared
ClearedNuVasive Next Generation 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 16, 2017 as substantially equivalent to K152942 (Nu Vasive, Incorporated, 2016) and 1 other predicate after a 210-day review. Its family tree reaches back 12 generations to 1984. 7 later devices descend from it.
- Decided
- Mar 16, 2017
- Review
- 210 days
- Class
- Class II
- Product code
- PDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K842956 (1984). 74 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 8 generations between
- 3 generations backK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- 2 generations backK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- 1 generation backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- This deviceK162313 NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 3 of its ownK180038 NuVasive Pulse SystemNu Vasive, Incorporated · 2018
- Descendant · 2 generations on · 2 of its ownK210574 NuVasive Pulse SystemNu Vasive, Incorporated · 2021 · Recalled
- Descendant · cites it directly · 2 of its ownK173526 SENTIO MMG Gen 2Medos International SARL · 2018
- Descendant · 2 generations on · 1 of its ownK243636 Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK260992 iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe…Neuralytix · 2026
Show all 12 generations
- Root · 12 generations backK842956 Nicolet VikingNicolet Biomedical Instruments · 1984
- 11 generations backK971819 Epoch 2000 Neurological WorkstationAxon Systems, Inc. · 1997
- 10 generations backK022785 Epoch XP Neurological Workstation; Epoch XP Lite Neurological…Axon Systems, Inc. · 2002
- 9 generations backK032741 Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationAxon Systems, Inc. · 2003
- 8 generations backK050798 Eclipse Neurological WorkstationAxon Systems, Inc. · 2005
- 7 generations backK061113 OrthomonAxon Systems, Inc. · 2006
- 6 generations backK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- 5 generations backK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- 4 generations backK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- 3 generations backK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- 2 generations backK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
- 1 generation backK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016
- This deviceK162313 NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K180038NuVasive Pulse SystemNu Vasive, Incorporated · 2018 · cites it directly3descendants
- K210574NuVasive Pulse SystemNu Vasive, Incorporated · 2021 · 2 generations on2descendants
- K173526SENTIO MMG Gen 2Medos International SARL · 2018 · cites it directly2descendants
- K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC · 2025 · 2 generations on1descendant
- K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…Neuralytix · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K842956 | Nicolet Viking | Nicolet Biomedical Instruments | 1984 | — |
| −11 | K971819 | Epoch 2000 Neurological Workstation | Axon Systems, Inc. | 1997 | — |
| −10 | K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological Workstation | Axon Systems, Inc. | 2002 | — |
| −9 | K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological Workstation | Axon Systems, Inc. | 2003 | — |
| −8 | K050798 | Eclipse Neurological Workstation | Axon Systems, Inc. | 2005 | — |
| −7 | K061113 | Orthomon | Axon Systems, Inc. | 2006 | — |
| −6 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| −5 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| −4 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| −3 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| −2 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
| −1 | K152942 | NuVasiveNVM5 System | Nu Vasive, Incorporated | 2016 | — |
| 0 (this device) | K162313 | NuVasive Next Generation NVM5 System | Nu Vasive, Incorporated | 2017 | — |
| +1 | K180038 | NuVasive Pulse System | Nu Vasive, Incorporated | 2018 | — |
| +2 | K210574 | NuVasive Pulse System | Nu Vasive, Incorporated | 2021 | 1 |
| +1 | K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018 | — |
| +2 | K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025 | — |
| +3 | K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006)… | Neuralytix | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K152942 | NuVasiveNVM5 SystemSummary page 4…dicate Devices The subject NuVasive Next Generation (NG) NVM5 System is substantially equivalent to the following predicate devices: NuVasive NVM5 System K152942 (Primary Predicate) Medtronic NIM 3.0 Nerve Integrity Monitor K083124 (Additional Predicate) NuVasive NVM5 System K1326… | 2016 |
| * | K083124 | NIM 3.0Summary page 4…s substantially equivalent to the following predicate devices: NuVasive NVM5 System K152942 (Primary Predicate) Medtronic NIM 3.0 Nerve Integrity Monitor K083124 (Additional Predicate) NuVasive NVM5 System K132694 (Reference Predicate for current density of the cutaneous electrode… | 2009 |
| † | K132694 | Nuvasive NVM5 System | 2014 |
What descends from it? (7)
2 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 33 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 9 of the 74 ancestors have a recall of any class.
- Of its descendants, K180038 (Nu Vasive, Incorporated, 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K152942.
How does its category compare?
All PDQ devicesPDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Next Generation NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. 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…
Read the full statement (383 words)
The Next Generation NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. 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 or lumbar motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates BendiniTM 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 evaltiate 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 alive 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 ofLl-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 ME? 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 Access - The remote monitoring and local wireless control provides real-time capabilities to the NG-NVM5 System for additional physicians.
• 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 as stated in the FDA summary.
https://510kreport.com/device/K162313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162313: NuVasive Next Generation 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/K162313
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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