# K221821: ATEC IOM Accessory Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Sep 23, 2022 after 92 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: 18 generations back to K941811 (1994). 317 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 319 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191723: ATEC IOM Accessory Instruments, Alphatec Spine, Inc. (2019) Summary page 4.
- K171807: ES2 Neuromonitoring Accessory Instruments, Stryker Corporation (2017) Summary page 4.
- K110989: Neurovision Ink Printed Endotracheal Tube Electrode, Neurovision Medical Products, Inc. (2011) Summary page 4.
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress, Inomed Medizintechnik GmbH (2022) Summary page 4.

## Most influential descendants
- 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/K221821
Methodology: https://510kreport.com/methodology