# K232413: Fusion Robotic Navigation System

- Pathway: 510(k) (Special)
- Applicant: Alphatec Spine, Inc.
- Decided: Sep 8, 2023 after 29 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: 22 generations back to K040583 (2004). 554 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 557 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.
- K231098: LineSider® Spinal System, Integrity Implants, Inc. (2023) Summary page 4.

## Most influential descendants
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own

## Indications for use
The Fusion Robotic Navigation System is indicated 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. The Fusion 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 ATEC Invictus® Spinal Fixation System.

Source page: https://510kreport.com/device/K232413
Methodology: https://510kreport.com/methodology