# K142438: Nerve Monitoring Cable System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.)
- Decided: Mar 5, 2015 after 188 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: 10 generations back to K950697 (1995). 123 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073229: Nerve Monitoring Cable, Pioneer Surgical Technology (2008) Summary page 4.
- K132373: Biomet Access System, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 4.
- K140400: ES2 Neuromonitoring Accessory Instruments, Stryker Corporation (2014) Summary page 4.

## Most influential descendants
- K182617: ATEC IOM Accessory Instruments (2019), 3 descendants of its own
- K191723: ATEC IOM Accessory Instruments (2019), 2 descendants of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own
- K223765: ATEC Lateral Navigation Instruments (2023), 0 descendants of its own

## Indications for use
The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery. The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site to allow passage of current from a point on the proximal end to an uninsulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The dilators are offered sterile/single use.

Source page: https://510kreport.com/device/K142438
Methodology: https://510kreport.com/methodology