# K252214: AIAS Cephalon

- Pathway: 510(k) (Traditional)
- Applicant: Metamorphosis GmbH
- Decided: Oct 7, 2025 after 84 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: 12 generations back to K896095 (1990). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210136: PhantomMSK Hip, OrthoGrid Systems, Inc. (2021) Summary page 5.

## Indications for use
AIAS Cephalon is an image-processing software indicated to assist in the positioning of femur fracture implant components for adult patients. It is intended to assist in precisely positioning femur fracture implant components intraoperatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images (C-arm images). Clinical judgement and experience are required to properly use the device. The device is not for primary image interpretation. The software is not for use on mobile phones.

Source page: https://510kreport.com/device/K252214
Methodology: https://510kreport.com/methodology