# K223350: Remi Robotic Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Robotics, LLC
- Decided: Mar 13, 2023 after 131 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: 21 generations back to K040583 (2004). 429 ancestors in all.
No later device cites it as a predicate yet.
1 of 430 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223070: Remi Robotic Navigation System, Fusion Robotics, LLC (2022) Summary page 4.
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 4.

## Indications for use
The Remi Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan or 2D fluoroscopic images. The Remi Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Accelus LineSider Spinal System.

Source page: https://510kreport.com/device/K223350
Methodology: https://510kreport.com/methodology