# K232149: BowTie™ SI Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Sail Fusion, LLC
- Decided: Apr 20, 2024 after 276 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: 17 generations back to K841189 (1984). 127 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221047: SILO TFX MIS Sacroiliac Joint Fixation System, Aurora Spine, Inc. (2022) Summary page 4.

## Most influential descendants
- K242431: Omnia Medical PsiF DNA™ System (2025), 1 descendant of its own
- K250894: Eminent Spine Posterior SI System (2025), 0 descendants of its own

## Indications for use
The BowTie™ SI Joint Fusion System is indicated for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the BowTie SI Fusion System is implanted, both the Iliac and Transfix Screw components must be used.

Source page: https://510kreport.com/device/K232149
Methodology: https://510kreport.com/methodology