# K251365: OptumSI Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Si Solutions, LLC
- Decided: Nov 20, 2025 after 203 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). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193524: SI-BONE iFuse Implant System®, SI-BONE, Inc. (2020) Summary page 5.

## Indications for use
The OptumSI Implant 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 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/K251365
Methodology: https://510kreport.com/methodology