# K260077: OrthoGrid Hip AI® 4.0

- Pathway: 510(k) (Traditional)
- Applicant: OrthoGrid Systems, Inc.
- Decided: May 29, 2026 after 137 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
OrthoGrid Hip AI® 4.0 is an image-processing software indicated to assist in the positioning of Total Hip Replacement components. The software uses Artificial Intelligence (AI) to allow real-time initialization of grid placement relative to the bone structures of interest in C-arm fluoroscopic images to assist in precisely positioning Total Hip Replacement components intraoperatively by measuring their positions. Artificial Intelligence will only offer automated initialization of grid placement if the points of interest can be identified from radiology 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/K260077
Methodology: https://510kreport.com/methodology