# K180038: NuVasive Pulse System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jun 29, 2018 after 175 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K040583 (2004). 221 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162313: NuVasive Next Generation NVM5 System, Nu Vasive, Incorporated (2017) Summary page 5.
- K173314: LessRay System, Nu Vasive, Incorporated (2017) Summary page 5.
- K170011: StealthStation S8 Spine Software v1.0.0, Medtronic Navigation (2017) Summary page 5.
- K172623: NuVasive Navigation Instruments, Nu Vasive, Incorporated (2017) Summary page 5.

## Most influential descendants
- K210574: NuVasive Pulse System (2021), 2 descendants of its own
- K243814: NuVasive Pulse System (2025), 0 descendants of its own
- K230989: Rod Registration Frame (2023), 0 descendants of its own

## Indications for use
The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse NVM5 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. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), 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 Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System. • 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. The Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease. Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 2D or 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy. This may include the following spinal implant procedures: o Pedicle Screw Placement (2D Navigation in Sacral and Lumbar Spine and 3D Navigation in Sacral and Thoracolumbar Spine) o Interbody Device Placement (2D and 3D Navigation in Lumbar Spine via Lateral Approach)

Source page: https://510kreport.com/device/K180038
Methodology: https://510kreport.com/methodology