# K253611: Falco Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Mcnicoll Surgical, Inc.
- Decided: Jan 29, 2026 after 72 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 K930834 (1993). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181881: Outlet Sacroiliac Joint Fusion System, Sij Surgical (2018) Summary page 5.
- K213590: Blue Topaz Sacroiliac Screw System, Osseus Fusion Systems, LLC (2022) Summary page 5.
- K201538: Life Spine SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2020) Summary page 5.

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

Source page: https://510kreport.com/device/K253611
Methodology: https://510kreport.com/methodology