# K233595: Genesys Spine Sacroiliac Joint Fusion System with Navigation

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Mar 29, 2024 after 142 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K841189 (1984). 135 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 137 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172268: iFuse Implant System- iFuse Navigation, SI-BONE, Inc. (2017) Summary page 4.
- K191748: Genesys Spine Sacroiliac Joint Fusion System, Genesys Spine (2019) 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.
- K150216: Synergy Cranial, Medtronic Navigation, Inc. (2015) Summary page 4.

## Most influential descendants
- K252322: SIros-X System (2025), 0 descendants of its own

## Indications for use
The Genesys Spine Sacroiliac Joint Fusion System with Navigation is intended to be used with the Genesys Spine Sacroiliac Joint Fusion System to assist the surgeon in precisely locating anatomical structures in Siros and Slros O procedures, in which the use of stereotactic surgery may be appropriate, and where reference to anatomical structures, such as the pelvis or vertebra, can be identified relative to acquired imaging (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or image data based models of the anatomy. Navigation instruments are intended to be used with the Medtronic O-arm® Imaging System and StealthStation® Navigation System.

Source page: https://510kreport.com/device/K233595
Methodology: https://510kreport.com/methodology