# K230700: RIWOtrack Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Fiagon GmbH
- Decided: Nov 20, 2023 after 252 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: 5 generations back to K050438 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192663: Joimax Intracs System, Joimax GmbH (2020) Summary page 4.

## Indications for use
The RIWOtrack Navigation System is intended to continuously display the position and orientation of RIWOspine surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures. The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal procedures, where the target point for the procedure itself or for the access to the area of interest, is a rigid landmark, such as: • Transforaminal procedure • Interlaminar procedure

Source page: https://510kreport.com/device/K230700
Methodology: https://510kreport.com/methodology