# K250894: Eminent Spine Posterior SI System

- Pathway: 510(k) (Traditional)
- Applicant: Eminent Spine
- Decided: Oct 7, 2025 after 196 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: 23 generations back to K930834 (1993). 227 ancestors in all.
No later device cites it as a predicate yet.
0 of 228 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190580: NADIA SI Fusion System, Ilion Medical, Inc. (2020) Summary page 5.
- K242431: Omnia Medical PsiF DNA™ System, Omnia Medical, LLC (2025). Cleared while this submission was under review Summary page 5.
- K240505: Eminent Spine SI Screw System, Eminent Spine, LLC (2024) Summary page 5.

## Indications for use
The Eminent Spine Posterior SI System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

Source page: https://510kreport.com/device/K250894
Methodology: https://510kreport.com/methodology