# K203110: iFuse Implant System - iFuse Navigation

- Pathway: 510(k) (Special)
- Applicant: SI-BONE, Inc.
- Decided: Nov 9, 2020 after 25 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: 14 generations back to K930834 (1993). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have 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.

## Most influential descendants
- K220024: ChoiceSpine Navigation System (2022), 0 descendants of its own

## Indications for use
iFuse-Implant System - iFuse-Navigation Instrument Set is intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in iFuse 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-Navigation instruments are intended to be used with the Medtronic StealthStation System.

Source page: https://510kreport.com/device/K203110
Methodology: https://510kreport.com/methodology