# K213768: Bolt Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Circinus Medical Technology, LLC
- Decided: Dec 1, 2022 after 365 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K013841 (2002). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200360: TrackX, Track X Technology, LLC (2020) Summary page 5.

## Indications for use
The Bolt Navigation System assists in the accurate placement of pedicle screws when used in conjunction with an intraoperative fluoroscope. It utilizes intraoperative fluoroscopic and pre- operative MRI or CT axial images to provide surgical planning and navigational telemetry relative to gravity, based on a fixed entry point ascertained by the user and validated by intraoperative fluoroscopic imaging. It is not intended to track patient position. The System is indicated for open and minimally invasive pedicle screw placement using a posterior approach in the thoracolumbar and sacral spine (T-9 to S1) where the patients’ relevant rigid anatomical structures can be clearly identified on the imaging.

Source page: https://510kreport.com/device/K213768
Methodology: https://510kreport.com/methodology