# K190580: NADIA SI Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Ilion Medical, Inc.
- Decided: Aug 5, 2020 after 518 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: 16 generations back to K841189 (1984). 123 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), Tenon Medical, Inc. (2018) Summary page 4.
- K112028: SI-Lok Sacroiliac Joint Fixation System, Globus Medical, Inc. (2011) Summary page 4.
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.

## Most influential descendants
- K232259: Patriot-SI Posterior Implant System (2024), 1 descendant of its own
- K250894: Eminent Spine Posterior SI System (2025), 0 descendants of its own
- K250001: Patriot SI Implant System (2025), 0 descendants of its own

## Indications for use
The NADIA SI Fusion System is for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K190580
Methodology: https://510kreport.com/methodology