# K241895: Cannulated PsiFGuard

- Pathway: 510(k) (Traditional)
- Applicant: Spineguard
- Decided: Sep 26, 2024 after 90 days
- Product code: SCY (Sacroiliac Joint Guidewire Placement Device)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K841189 (1984). 127 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221047: SILO TFX MIS Sacroiliac Joint Fixation System, Aurora Spine, Inc. (2022) Summary page 5.

## Indications for use
The Cannulated PsiFGuard is an accessory to systems intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. It is indicated for use during sacroiliac joint guidewire placement to provide feedback to the surgeon via visual and audible alerts that indicate a change in conductivity at the tip of the probe and may indicate contact of the tip with bone and possible cortex perforation.

Source page: https://510kreport.com/device/K241895
Methodology: https://510kreport.com/methodology