# K261060: Navigated LLIF Impactable Tracker

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: May 29, 2026 after 59 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: 31 generations back to K841189 (1984). 610 ancestors in all.
No later device cites it as a predicate yet.
1 of 611 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252742: Navigated Instruments, Tyber Medical, LLC (2025) Summary page 5.
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps, Medtronic Navigation, Inc. (2013) Summary page 6.

## 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™ 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/K261060
Methodology: https://510kreport.com/methodology