# K210667: FIREBIRD SI Fusion System

- Pathway: 510(k) (Special)
- Applicant: Orthofix, Inc.
- Decided: Mar 25, 2021 after 20 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: 18 generations back to K930834 (1993). 38 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203138: FIREBIRD SI Fusion System, Orthofix, Inc. (2020) Summary page 4.

## Most influential descendants
- 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
- K223708: Entasis 3D Dual-Lead Sacroiliac Implant System (2023), 3 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/K210667
Methodology: https://510kreport.com/methodology