# K213272: Formus Hip

- Pathway: 510(k) (Traditional)
- Applicant: Formus Labs, Ltd.
- Decided: Mar 31, 2023 after 547 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: 9 generations back to K896095 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182464: PeekMed, Peek Health, S.A. (2018) Summary page 4.

## Indications for use
Formus Hip is a pre-operative planning software for orthopedic surgery. The standalone software application imports patient diagnostic imaging studies (e.g. pre-dimensioned CT scans) from PACS-systems or other conventional medias. The Formus Hip system contains an integrated database of orthopedic hip implant geometries that can be overlayed to assist surgeons in their planning of orthopedic hip surgeries. The software application further enables the healthcare professional to customize their preoperative planning by means of an interactive graphical user interface. Finalized plans can be printed to a PDF report. The qualified healthcare professional can digitally perform the surgical planning and also make it available as a printable report. Clinical judgment and experience with the software are required for its successful use.

Source page: https://510kreport.com/device/K213272
Methodology: https://510kreport.com/methodology