# K161755: Integrity-SI TM Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Coorstek Medical
- Decided: Dec 14, 2016 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: 7 generations back to K903810 (1990). 23 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.
- K141549: SImmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2015) Summary page 4.
- K110472: SI-Fix Sacroiliac Joint Fusion System, Medtronic Sofamor Danek (2012) Summary page 4.

## Most influential descendants
- K222512: Integrity-SI Fusion System (2022), 1 descendant of its own
- K230226: Integrity-SI® Fusion System (2023), 0 descendants of its own

## Indications for use
The Integrity-SI Fusion System device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K161755
Methodology: https://510kreport.com/methodology