# K112717: Nuvasive Nvjjb System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Apr 13, 2012 after 207 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: 8 generations back to K923056 (1992). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 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). Cleared while this submission was under review Summary page 1.
- K061113: Orthomon, Axon Systems, Inc. (2006) 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.
- K061148: Rhythmlink Disc Electrodes, Rhythmlink International, LLC (2006) Summary page 1.
- K022914: Rhythmlink International Subdermal Needle Electrodes, Rhythmlink International, LLC (2002) Summary page 1.
- K112709: Stimulation/Dissection Instruments, Nu Vasive, Incorporated (2012). Cleared while this submission was under review

## Indications for use
The NVJJB® System is a medical device that is intended for intraoperative neurophysiological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiological status. NVJJB® provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG) or transcranial motor evoked potential (TcMEP) responses of nerves. * MaXcess Detection - The MaXcess Detection function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool * Difference Screw Test (DST) - The DST function allows the surgeon to locate and evaluate spinal nerves before, during, or after placement of bone screws by verifying nerve integrity and factoring it into the alarm criteria. * 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 and motor pathway integrity during procedures with a risk of surgically induced motor injury. * Remote Reader - The Remote Reader function provides real time remote access to the NVJJB System for a monitoring physician outside of the operating room. * Nerve Retractor- The Nerve Retractor function allows the surgeon to locate and identify spinal nerves by directly stimulating exposed nerves to assist in identifying neurophysiological changes during retraction.

Source page: https://510kreport.com/device/K112717
Methodology: https://510kreport.com/methodology