# K242270: OrthoNext Platform System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Dec 19, 2024 after 140 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K896095 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202519: OrthoNext Platform System, Orthofix Srl (2020) Summary page 5.

## Indications for use
The OrthoNext™ Platform System is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery and post-operative planning of orthopedic treatment. The device allows for overlaying of Orthofix Product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.

Source page: https://510kreport.com/device/K242270
Methodology: https://510kreport.com/methodology