# K241813: SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Si-Technology, LLC
- Decided: Aug 13, 2024 after 53 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: 17 generations back to K841189 (1984). 134 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190230: iFuse Implant System®, SI-BONE, Inc. (2019) Summary page 4.
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), Tenon Medical, Inc. (2018) Summary page 4.
- K231944: CATAMARAN SI Joint Fusion System, Tenon Medical, Inc. (2023) Summary page 4.
- K151462: SI-Technology® SI-Desis® Screws, Si-Technology, LLC (2015) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.

## Most influential descendants
- K251525: SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (2025), 0 descendants of its own

## 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/K241813
Methodology: https://510kreport.com/methodology