# K200868: SI-Restore Sacroiliac Joint Fixation System

- Pathway: 510(k) (Special)
- Applicant: Biofusion Medical
- Decided: Apr 17, 2020 after 16 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: 7 generations back to K903810 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182919: SI-Restore® Sacroiliac Joint Fixation System, Biofusion Medical (2019) Summary page 4.

## Indications for use
The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation Screw is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K200868
Methodology: https://510kreport.com/methodology