# K260992: iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)

- Pathway: 510(k) (Traditional)
- Applicant: Neuralytix
- Decided: Jun 25, 2026 after 91 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: 15 generations back to K842956 (1984). 98 ancestors in all.
No later device cites it as a predicate yet.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243636: Neuralytix iD3 System (NTX-9001), Neuralytix, LLC (2025) Summary page 5.

## 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 biologic 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/K260992
Methodology: https://510kreport.com/methodology