# K252742: Navigated Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Oct 28, 2025 after 61 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: 30 generations back to K841189 (1984). 609 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 611 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221180: Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments, Medtronic Sofamor Danek USA, Inc. (2022) Summary page 5.
- K192336: Navigated Anterolateral Disc Prep Instruments, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 5.

## Most influential descendants
- K261060: Navigated LLIF Impactable Tracker (2026), 0 descendants of its own

## Indications for use
The Navigated Instruments are intended to be used during preparation and placement of Medtronic Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instruments are specifically designed for use with the Medtronic StealthStation T M 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 a 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/K252742
Methodology: https://510kreport.com/methodology