# K232345: ATEC Posterior Navigated Disc Prep Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Nov 2, 2023 after 90 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K841189 (1984). 575 ancestors in all.
2 later devices descend from it; 1 cites it directly.
5 of 578 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology, Medtronic Sofamor Danek (2020) Summary page 5.
- K211441: Navigated Anterolateral Disc Prep Instruments, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 5.

## Most influential descendants
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own

## Indications for use
The ATEC Posterior Navigated Disc Prep Instruments are indicated to facilitate discectomy, bony 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.

Source page: https://510kreport.com/device/K232345
Methodology: https://510kreport.com/methodology