# K222512: Integrity-SI Fusion System

- Pathway: 510(k) (Special)
- Applicant: OsteoCentric Technologies
- Decided: Sep 12, 2022 after 24 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: 16 generations back to K930834 (1993). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161755: Integrity-SI TM Fusion System, Coorstek Medical (2016) Summary page 4.
- K193524: SI-BONE iFuse Implant System®, SI-BONE, Inc. (2020) Summary page 4.

## Most influential descendants
- K230226: Integrity-SI® Fusion System (2023), 0 descendants of its own

## Indications for use
The Integrity-SI Fusion System is intended for sacroiliac joint fusion for the following conditions: 1. 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. 2. To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. 3. Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint

Source page: https://510kreport.com/device/K222512
Methodology: https://510kreport.com/methodology