# K240505: Eminent Spine SI Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Eminent Spine, LLC
- Decided: Jun 4, 2024 after 104 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: 22 generations back to K930834 (1993). 221 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223708: Entasis 3D Dual-Lead Sacroiliac Implant System, Corelink, LLC (2023) Summary page 4.

## Most influential descendants
- K250894: Eminent Spine Posterior SI System (2025), 0 descendants of its own

## Indications for use
The Eminent Spine SI Screw 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 and acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. 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/K240505
Methodology: https://510kreport.com/methodology