# K221047: SILO TFX MIS Sacroiliac Joint Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Spine, Inc.
- Decided: Oct 3, 2022 after 178 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). 126 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 5.
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), Tenon Medical, Inc. (2018) Summary page 5.
- K151818: SImmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2015) Summary page 5.

## Most influential descendants
- K230857: TiLink-P SI Joint Fusion System (2023), 4 descendants of its own
- K240720: TiLink-P SI Joint Fusion System (2024), 3 descendants of its own
- K232149: BowTie™ SI Joint Fusion System (2024), 2 descendants of its own
- K242431: Omnia Medical PsiF DNA™ System (2025), 1 descendant of its own
- K242141: TiLink-P SI Joint Fusion System (2024), 1 descendant of its own

## Indications for use
The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K221047
Methodology: https://510kreport.com/methodology