Orthopedics
OrthoGrid Hip AI 4.0
OrthoGrid Systems, Inc.
Image-processing software indicated to assist in positioning total hip replacement components. It uses artificial intelligence to initialise grid placement relative to the bone structures of interest in C-arm fluoroscopic images in real time, so that component positions can be measured intraoperatively; the automated initialisation is offered only when the points of interest can be identified in the image. The indications state that clinical judgement and experience are required, that the device is not for primary image interpretation and that it is not for use on mobile phones.
FDA Submission Metadata
- Submission number
- K260077
- Decision date
- May 2026
- FDA panel
- Radiology
- Product code
- QIH
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals