# K200696: FIREBIRD SI Fusion System

- Pathway: 510(k) (Special)
- Applicant: Orthofix, Inc.
- Decided: Apr 2, 2020 after 16 days
- Product code: OUR (Sacroiliac Joint Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K930834 (1993). 35 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183342: SambaScrew 3D SI Fusion System, Orthofix, Inc. (2019) Summary page 4.

## Most influential descendants
- K201664: FIREBIRD SI Fusion System (2020), 26 descendants of its own
- K203138: FIREBIRD SI Fusion System (2020), 25 descendants of its own
- 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

## Recalls of this device
- Nov 3, 2025 · Class III · Z-0894-2026: Labeling contains claims that are not consistently present.

## 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 and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K200696
Methodology: https://510kreport.com/methodology