# K241961: Vent Creativity Knee v1.0 (Hermes)

- Pathway: 510(k) (Traditional)
- Applicant: Vent Creativity
- Decided: Mar 20, 2025 after 260 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: 6 generations back to K924630 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203195: Simpleware ScanIP Medical, Synopsys (Northern Europe), Ltd. (2021) Summary page 5.
- (no number) Synopsys: named in the summary without a submission number
- (no number) Mimics: named in the summary without a submission number

## Indications for use
Hermes is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as preoperative software for diagnostic and surgical planning. For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic applications. The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.

Source page: https://510kreport.com/device/K241961
Methodology: https://510kreport.com/methodology