# K203138: FIREBIRD SI Fusion System

- Pathway: 510(k) (Special)
- Applicant: Orthofix, Inc.
- Decided: Nov 18, 2020 after 29 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). 37 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201664: FIREBIRD SI Fusion System, Orthofix, Inc. (2020) Summary page 4.

## Most influential descendants
- K210667: FIREBIRD SI Fusion System (2021), 19 descendants of its own
- K213667: iFuse-TORQ® Implant System (2022), 15 descendants of its own
- K222605: iFuse TORQ® Implant System (2022), 14 descendants of its own
- K231689: iFuse TORQ® Implant System (2023), 5 descendants of its own
- K241574: iFuse TORQ® Implant System (2024), 4 descendants of its own

## Indications for use
The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including; * sacroiliac joint disruptions, * degenerative sacroiliitis, * to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and * Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Source page: https://510kreport.com/device/K203138
Methodology: https://510kreport.com/methodology