# K140400: ES2 Neuromonitoring Accessory Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Jul 1, 2014 after 133 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: 9 generations back to K950697 (1995). 98 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112718: Nuvasive NVM5 System, Nuvasive, Inc. (2012)
- K123307: Nuvasive NVM5 System, Nuvasive, Inc. (2013) Summary page 1.
- K122845: ES2 Spinal System Model 48280XXXX, Stryker Spine (2012) Summary page 1.

## Most influential descendants
- K171807: ES2 Neuromonitoring Accessory Instruments (2017), 7 descendants of its own
- K142438: Nerve Monitoring Cable System (2015), 4 descendants of its own
- K182617: ATEC IOM Accessory Instruments (2019), 3 descendants of its own
- K191723: ATEC IOM Accessory Instruments (2019), 2 descendants of its own
- K190163: ALARA Neuro Access Kit (2019), 2 descendants of its own

## Indications for use
The ES2® Awl, ES2® Taps, and ES2® Screwdriver can be used to assist in location of the spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws in open and percutaneous minimally invasive posterior surgical approaches of the non-cervical spine.

Source page: https://510kreport.com/device/K140400
Methodology: https://510kreport.com/methodology