# K191748: Genesys Spine Sacroiliac Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Sep 26, 2019 after 87 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: 15 generations back to K841189 (1984). 125 ancestors in all.
22 later devices descend from it; 6 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123702: Silex Sacroiliac Joint Fusion System, X-Spine Systems, Inc. (2013) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.
- K080398: SI Joint Fusion System, SI-BONE, Inc. (2008) Summary page 4.
- K092375: Modification to SI Joint Fusion System, SI-BONE, Inc. (2009) Summary page 4.
- K141549: SImmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2015) Summary page 4.
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 4.

## Most influential descendants
- K203247: iFuse-TORQ™ Implant System (2021), 17 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
- K231689: iFuse TORQ® Implant System (2023), 5 descendants of its own
- K241574: iFuse TORQ® Implant System (2024), 4 descendants of its own

## Indications for use
The Genesys Spine Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including degencrative sacroiliitis and sacroiliac joint disruptions.

Source page: https://510kreport.com/device/K191748
Methodology: https://510kreport.com/methodology