# K123390: Pediguard Nerve Detector System

- Pathway: 510(k) (Traditional)
- Applicant: Spineguard S.A.
- Decided: Aug 8, 2013 after 279 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: 4 generations back to K921979 (1993). 7 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030526: Pediguard Nerve Detector System, Spine Vision, Inc. (2004) Summary page 1.

## Most influential descendants
- K143159: Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS (2015), 4 descendants of its own
- K152747: DSG Threaded Drill System (2016), 3 descendants of its own
- K162884: SpineGuard DSG Zavation Screw System (2017), 2 descendants of its own
- K201454: DSG Connect Technology (2021), 1 descendant of its own
- K222106: Waypoint GPS (2023), 0 descendants of its own

## Indications for use
The PediGuard® 2.5mm XS (model P1-AU414), PediGuard® Curv XS (model P1-AU451) and Cannulated PediGuard® Needle#2 (model P2ZND1002) are indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

Source page: https://510kreport.com/device/K123390
Methodology: https://510kreport.com/methodology