# K222605: iFuse TORQ® Implant System

- Pathway: 510(k) (Special)
- Applicant: SI-BONE, Inc.
- Decided: Sep 29, 2022 after 31 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: 20 generations back to K930834 (1993). 148 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213667: iFuse-TORQ® Implant System, SI-BONE, Inc. (2022) Summary page 4.
- K203247: iFuse-TORQ™ Implant System, SI-BONE, Inc. (2021) Summary page 4.
- K190230: iFuse Implant System®, SI-BONE, Inc. (2019) Summary page 4.
- K182983: iFuse Implant System®, SI-BONE, Inc. (2018) Summary page 4.
- K172268: iFuse Implant System- iFuse Navigation, SI-BONE, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K243565: DYNAMIS™ SI Screw System (2025), 1 descendant of its own

## Indications for use
The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for: • Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. • Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures. The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORQ Navigation instruments are intended to be used with the Medtronic StealthStation System.

Source page: https://510kreport.com/device/K222605
Methodology: https://510kreport.com/methodology