# K171807: ES2 Neuromonitoring Accessory Instruments

- Pathway: 510(k) (Special)
- Applicant: Stryker Corporation
- Decided: Jul 18, 2017 after 29 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). 99 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K190163: ALARA Neuro Access Kit (2019), 2 descendants of its own
- K240664: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (2024), 1 descendant of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own

## Indications for use
The ES2 Neuromonitoring instruments (Awls, Taps, Screwdriver and LITe Y-NEEDLE 200, 300 and 400) can be used by the surgeon 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/K171807
Methodology: https://510kreport.com/methodology