# K243636: Neuralytix iD3 System (NTX-9001)

- Pathway: 510(k) (Traditional)
- Applicant: Neuralytix, LLC
- Decided: Jun 26, 2025 after 213 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: 14 generations back to K842956 (1984). 97 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173526: SENTIO MMG Gen 2, Medos International SARL (2018) Summary page 5.

## Most influential descendants
- K260992: iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) (2026), 0 descendants of its own

## Indications for use
This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure. The device is intended to identify relative changes in the conduction and neural transmission ability of the nerve throughout a surgical procedure by measuring and comparing the minimum amount of electrical stimulation current (mA) required to induce a measurable MMG response (MMG nerve response threshold). Examples of surgical applications which may require mechanomyographic (MMG) monitoring: • Minimally invasive and open spinal surgery involving spinal fusion cages, screws, rods, plates, discs and biologics. • Minimally invasive, open and endoscopic, direct and indirect nerve decompressions, discectomies, laminectomies, laminotomies, facetectomies, foraminotomies. • Treatment of nerve compression, stenosis, degenerative disc disease, disc herniation, spondylolisthesis.

Source page: https://510kreport.com/device/K243636
Methodology: https://510kreport.com/methodology