# K251992: ArmSure Fluoroscopic Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Savfe Co., Ltd.
- Decided: Feb 11, 2026 after 229 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)
- K173736: TrackX, Track X Technology, LLC (2018) Summary page 5.
- K200360: TrackX, Track X Technology, LLC (2020) Summary page 5.

## Indications for use
The ArmSure Fluoroscopic Positioning System is a software-enabled manual Assist Arm intended for use with fluoroscopic systems to assist in the visualization of the spatial relationship of attached compatible surgical instruments and interventional accessories on X-ray images, and to maintain the corresponding spatial position to hold the attached instrument or accessory. The ArmSure system is intended to be used by trained healthcare professionals in a clinical environment, and is indicated for use during fluoroscopically-guided procedures involving the spine and long bones in patients whose anatomical size is suitable for the compatible instruments and the host fluoroscopic system.

Source page: https://510kreport.com/device/K251992
Methodology: https://510kreport.com/methodology