# K191723: ATEC IOM Accessory Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Oct 18, 2019 after 113 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: 12 generations back to K950697 (1995). 170 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182617: ATEC IOM Accessory Instruments, Alphatec Spine, Inc. (2019) Summary page 4.
- K132138: Rhythmlink Disposable Concentric Stimulating Probe, Rhythmlink International, LLC (2014) Summary page 4.

## Most influential descendants
- 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 ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

Source page: https://510kreport.com/device/K191723
Methodology: https://510kreport.com/methodology