# K243810: TraumaCad Neo (1.1)

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab, Ltd.
- Decided: Jun 4, 2025 after 175 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: 11 generations back to K896095 (1990). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231498: TraumaCad Neo, Brainlab, Ltd. (2023) Summary page 5.
- K222767: PeekMed web (v1), Peek Health, S.A. (2022) Summary page 5.

## Indications for use
TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software. The software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones.

Source page: https://510kreport.com/device/K243810
Methodology: https://510kreport.com/methodology