# K173134: SENTIO MMG Pedicle Access Needles

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Mar 22, 2018 after 174 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: 8 generations back to K923056 (1992). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 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 4.
- K112709: Stimulation/Dissection Instruments, Nu Vasive, Incorporated (2012) Summary page 4.

## Most influential descendants
- K223438: TELIGEN System Peripheral Motor Nerve Stimulation Indications (2023), 0 descendants of its own

## Indications for use
The SENTIO MMG Pedicle Access Needles are indicated for use in pedicle pilot hole preparation and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Source page: https://510kreport.com/device/K173134
Methodology: https://510kreport.com/methodology