# K213590: Blue Topaz Sacroiliac Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osseus Fusion Systems, LLC
- Decided: Mar 1, 2022 after 109 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: 9 generations back to K903810 (1990). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152237: The Entasis Dual-Lead Sacroiliac Implant, Corelink, LLC (2016) Summary page 5.
- K181881: Outlet Sacroiliac Joint Fusion System, Sij Surgical (2018) Summary page 5.
- K121148: Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM Dia., 35MM Long, Samba Screw, 9MM D, Medical Design, LLC (2012) Summary page 5.

## Most influential descendants
- K253611: Falco Fusion System (2026), 0 descendants of its own

## Indications for use
The Blue Topaz Sacroiliac Screw System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K213590
Methodology: https://510kreport.com/methodology