# K123307: Nuvasive NVM5 System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Apr 23, 2013 after 181 days
- Product code: PDQ (Neurosurgical Nerve Locator)
- 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: 7 generations back to K842956 (1984). 51 ancestors in all.
33 later devices descend from it; 2 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112718: Nuvasive NVM5 System, Nuvasive, Inc. (2012) Summary page 1.
- K122742: Nuvasive Bendini Spinal Rod Bending System, Nuvasive, Inc. (2012). Cleared while this submission was under review Summary page 1.
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 1.
- K012448: Vectorvision Trauma, Brainlab AG (2002) Summary page 1.

## Most influential descendants
- 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
- K140400: ES2 Neuromonitoring Accessory Instruments (2014), 9 descendants of its own

## Indications for use
The NVMV5® 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. NVMV5 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. 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 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 EMVG function identifies spontaneous EMVG 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. * 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 NVMV5 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 pedlicle cannulation procedures in the lumbar and sacral spine (Li-Si) 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.

Source page: https://510kreport.com/device/K123307
Methodology: https://510kreport.com/methodology