# K131304: Sentio MMG

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Surgical Solutions, LLC ("Iss")
- Decided: May 29, 2014 after 387 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: 6 generations back to K980148 (1998). 21 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100992: Neuralmas, Innovative Surgical Solutions, LLC ("Iss") (2010) Summary page 1.

## Most influential descendants
- K173526: SENTIO MMG Gen 2 (2018), 2 descendants of its own
- K243636: Neuralytix iD3 System (NTX-9001) (2025), 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/K131304
Methodology: https://510kreport.com/methodology