# K183342: SambaScrew 3D SI Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: Apr 30, 2019 after 148 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: 14 generations back to K930834 (1993). 34 ancestors in all.
31 later devices descend from it; 2 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121148: Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM Dia., 35MM Long, Samba Screw, 9MM D, Medical Design, LLC (2012) Summary page 4.
- K151818: SImmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2015) Summary page 4.
- K182983: iFuse Implant System®, SI-BONE, Inc. (2018) Summary page 4.
- K162733: iFuse Implant System® - iFuse-3D implant, SI-BONE, Inc. (2017) Summary page 5.

## Most influential descendants
- K200696: FIREBIRD SI Fusion System (2020), 29 descendants of its own
- 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

## Indications for use
The SambaScrew 3D 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/K183342
Methodology: https://510kreport.com/methodology