# K251525: SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

- Pathway: 510(k) (Special)
- Applicant: Si-Technology, LLC
- Decided: Jun 6, 2025 after 18 days
- Product code: OUR (Sacroiliac Joint Fixation)
- 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: 18 generations back to K841189 (1984). 135 ancestors in all.
No later device cites it as a predicate yet.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241813: SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System, Si-Technology, LLC (2024) Summary page 5.

## Indications for use
The SI-TECHNOLOGY® SI-DESIS® X ™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. The SI-TECHNOLOGY® SI-DESIS® X ™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

Source page: https://510kreport.com/device/K251525
Methodology: https://510kreport.com/methodology