# K223765: ATEC Lateral Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Mar 23, 2023 after 98 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K003155 (2001). 573 ancestors in all.
No later device cites it as a predicate yet.
2 of 574 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192336: Navigated Anterolateral Disc Prep Instruments, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 4.
- K221821: ATEC IOM Accessory Instruments, Alphatec Spine, Inc. (2022) Summary page 4.
- K200719: NuVasive Navigation.S Instruments, Nu Vasive, Incorporated (2020) Summary page 4.

## Recalls of this device
- Jan 2, 2026 · Class II · Z-1343-2026: Due a design issue where the navigated array connection geometry is incorrect.
- Jan 2, 2026 · Class II · Z-1342-2026: Due a design issue where the navigated array connection geometry is incorrect.

## Indications for use
The ATEC Lateral Navigation Instruments are intended to facilitate discectomy, boney resection, implant selection, and access during spinal surgery. Navigated instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The Stimulating Initial Dilator may also be 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/K223765
Methodology: https://510kreport.com/methodology