# K200360: TrackX

- Pathway: 510(k) (Special)
- Applicant: Track X Technology, LLC
- Decided: Mar 5, 2020 after 21 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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: 6 generations back to K013841 (2002). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173736: TrackX, Track X Technology, LLC (2018) Summary page 5.

## Most influential descendants
- K251992: ArmSure Fluoroscopic Positioning System (2026), 0 descendants of its own
- K213768: Bolt Navigation System (2022), 0 descendants of its own

## Recalls of this device
- Sep 3, 2024 · Class III · Z-0260-2025: The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the 
- Oct 24, 2022 · Class II · Z-1107-2023: The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.

## Indications for use
TrackX v.2.0 is intended for use in any application where a fluoroscope is incorporated to aid in the diagnosis and treatment of disease.

Source page: https://510kreport.com/device/K200360
Methodology: https://510kreport.com/methodology