# K203247: iFuse-TORQ™ Implant System

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: Feb 25, 2021 after 113 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: 16 generations back to K841189 (1984). 138 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193083: M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System, Medacta International S.A. (2019) Summary page 5.
- K193524: SI-BONE iFuse Implant System®, SI-BONE, Inc. (2020) Summary page 5.
- K191748: Genesys Spine Sacroiliac Joint Fusion System, Genesys Spine (2019) Summary page 5.

## 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

## Recalls of this device
- Aug 21, 2026 · Class II · Z-0146-2027: The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.

## 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 small and large bones of the pelvis

Source page: https://510kreport.com/device/K203247
Methodology: https://510kreport.com/methodology