# K223819: SI-Cure Sacroiliac Joint Fusion System

- Pathway: 510(k) (Special)
- Applicant: Alevio, LLC
- Decided: Jan 18, 2023 after 28 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 K930834 (1993). 140 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141106: Frontier Devices Fusio Screw Fuze System, Folsom Metal Products, Inc. Dba Frontier Devices (2014) Summary page 5.
- K212903: SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2021) Summary page 5.

## Most influential descendants
- K231951: SI-Cure Sacroiliac Joint Fusion System (2023), 1 descendant of its own
- K230226: Integrity-SI® Fusion System (2023), 0 descendants of its own

## Indications for use
The SI-Cure Sacroiliac Joint Fusion System is intended for sacroiliac fusion for the following conditions: * 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. * To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing acropelvic fixation as part of a lumbar or thoracolumbar fusion. * Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Source page: https://510kreport.com/device/K223819
Methodology: https://510kreport.com/methodology