# K230226: Integrity-SI® Fusion System

- Pathway: 510(k) (Special)
- Applicant: OsteoCentric Technologies
- Decided: Sep 21, 2023 after 237 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: 20 generations back to K930834 (1993). 276 ancestors in all.
No later device cites it as a predicate yet.
0 of 277 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222512: Integrity-SI Fusion System, OsteoCentric Technologies (2022) Summary page 4.
- K161755: Integrity-SI TM Fusion System, Coorstek Medical (2016) Summary page 4.
- K211290: Cannulated Fasteners and Nuts, OsteoCentric Technologies (2021) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.
- K231951: SI-Cure Sacroiliac Joint Fusion System, Alevio, LLC (2023). Cleared while this submission was under review Summary page 4.

## Indications for use
The Integrity-SI Fusion System is intended for sacroiliac joint 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 sacropelvic 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/K230226
Methodology: https://510kreport.com/methodology