# K141106: Frontier Devices Fusio Screw Fuze System

- Pathway: 510(k) (Traditional)
- Applicant: Folsom Metal Products, Inc. Dba Frontier Devices
- Decided: Oct 10, 2014 after 164 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: 6 generations back to K903810 (1990). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112028: SI-Lok Sacroiliac Joint Fixation System, Globus Medical, Inc. (2011) Summary page 4.
- K123702: Silex Sacroiliac Joint Fusion System, X-Spine Systems, Inc. (2013) Summary page 4.

## Most influential descendants
- K223819: SI-Cure Sacroiliac Joint Fusion System (2023), 2 descendants of its own
- K231951: SI-Cure Sacroiliac Joint Fusion System (2023), 1 descendant of its own
- K230226: Integrity-SI® Fusion System (2023), 0 descendants of its own

## Indications for use
The FUSIO Screw Fuze System is intended for large bone fixation, including sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K141106
Methodology: https://510kreport.com/methodology