# K112718: Nuvasive NVM5 System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Mar 16, 2012 after 179 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K842956 (1984). 44 ancestors in all.
35 later devices descend from it; 4 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962455: Four-Channel Preamplifier, Cadwell Laboratories, Inc. (1997) Summary page 1.
- K051357: DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator, Model DS7AH, Digitimer, Ltd. (2005) Summary page 1.
- K061113: Orthomon, Axon Systems, Inc. (2006) Summary page 1.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 1.
- K061148: Rhythmlink Disc Electrodes, Rhythmlink International, LLC (2006) Summary page 1.
- K022914: Rhythmlink International Subdermal Needle Electrodes, Rhythmlink International, LLC (2002) Summary page 1.

## Most influential descendants
- K123307: Nuvasive NVM5 System (2013), 33 descendants of its own
- K132694: Nuvasive NVM5 System (2014), 24 descendants of its own
- K141968: Nuvasive NVM5 System (2014), 23 descendants of its own
- K143641: NuVasive NVM5 System (2015), 22 descendants of its own
- K152942: NuVasiveNVM5 System (2016), 13 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K112718
Methodology: https://510kreport.com/methodology