# K100992: Neuralmas

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Surgical Solutions, LLC ("Iss")
- Decided: Sep 24, 2010 after 168 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: 5 generations back to K980148 (1998). 20 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031510: Nim-Spine, Medtronic Xomed (2003) Summary page 3.
- K072736: Rhythmlink International Monopolar Stimulating Instrument, Rhythmlink International, LLC (2008) Summary page 1.
- K062996: Disposable Monopolar and Bipolar Stimulator Probes, Axon Systems, Inc. (2007) Summary page 1.
- K000722: Unipolar Needles, Pajunk GmbH (2000) Summary page 1.

## Most influential descendants
- K131304: Sentio MMG (2014), 3 descendants of its own
- K173526: SENTIO MMG Gen 2 (2018), 2 descendants of its own
- K243636: Neuralytix iD3 System (NTX-9001) (2025), 1 descendant of its own
- K173134: SENTIO MMG Pedicle Access Needles (2018), 1 descendant of its own
- 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. This device is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.

Source page: https://510kreport.com/device/K100992
Methodology: https://510kreport.com/methodology