# K202519: OrthoNext Platform System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Oct 27, 2020 after 56 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 9 generations back to K896095 (1990). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142923: TraumaCad Mobile Release 1.0, Voyant Health, Ltd. (2015) Summary page 4.
- K073714: Traumacad Version 2.0, Orthocrat, Ltd. (2008) Summary page 4.

## Most influential descendants
- K242270: OrthoNext Platform System (2024), 0 descendants of its own

## Indications for use
The OrthoNext ™ Platform system is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. 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. The OrthoNext ™ Platform system is not to be used for mammography.

Source page: https://510kreport.com/device/K202519
Methodology: https://510kreport.com/methodology