# K213667: iFuse-TORQ® Implant System

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: Jun 10, 2022 after 200 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: 19 generations back to K930834 (1993). 146 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203247: iFuse-TORQ™ Implant System, SI-BONE, Inc. (2021) Summary page 4.
- K210667: FIREBIRD SI Fusion System, Orthofix, Inc. (2021) Summary page 4.

## Most influential descendants
- 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
- K231829: Xenix Medical Sacroiliac Fixation System (2023), 2 descendants of its own

## Indications for use
The iFuse-TORQ Implant System is indicated for: * Fusion of the sacroiliac joint for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis * Fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures

Source page: https://510kreport.com/device/K213667
Methodology: https://510kreport.com/methodology