# K160001: TraumaCad Mobile Release 2.0

- Pathway: 510(k) (Special)
- Applicant: Voyant Health, Ltd.
- Decided: Feb 12, 2016 after 39 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.
3 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K231498: TraumaCad Neo (2023), 1 descendant of its own
- K261352: 2D Hip Planning Software (2026), 0 descendants of its own
- K243810: TraumaCad Neo (1.1) (2025), 0 descendants of its own

## Indications for use
The TraumaCad Mobile Release 2.0 program is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

Source page: https://510kreport.com/device/K160001
Methodology: https://510kreport.com/methodology