# K162121: Siconus SI Joint Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Jan 18, 2017 after 170 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: 4 generations back to K903810 (1990). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123702: Silex Sacroiliac Joint Fusion System, X-Spine Systems, Inc. (2013) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.
- K102907: Simmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2010) Summary page 4.

## Most influential descendants
- K211785: CASSATT™ SIJ Fixation System (2022), 0 descendants of its own

## Indications for use
The SICONUS™ SI Joint Fixation System is intended to provide fixation and stabilization of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of degenerative sacroiliitis, or sacroiliac joint disruptions.

Source page: https://510kreport.com/device/K162121
Methodology: https://510kreport.com/methodology