# K230252: OFIX MIS App

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix US, LLC
- Decided: Sep 26, 2023 after 239 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: 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)
- K141669: Surgimap, Nemaris, Inc. (2014) Summary page 4.

## Indications for use
The OFIX MIS App software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The app allows service providers to plan surgical procedures by making measurements for the placement of surgical implants. Clinical judgement and experience are required to properly use the software.

Source page: https://510kreport.com/device/K230252
Methodology: https://510kreport.com/methodology