# K241696: Ortho AI

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Ai, LLC
- Decided: Jan 2, 2025 after 204 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: 8 generations back to K942948 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192109: KOALA, Ib Lab GmbH (2019) Summary page 5.

## Indications for use
Ortho Al is an image-processing software indicated to assist in making measurements for a total hip arthroplasty, total knee arthroplasty, and lumbar spine fusion surgery. It is intended to assist in the measurement of x-ray images by measuring lengths, angles and position of implants relative to the bone structures of interest provided, that the points of interest can be identified from radiology images. The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. The software is not for primary image interpretation. The software is not for use on mobile phones. Intended patient population: Adult patients >=22 years old, with appropriate imaging, undergoing primary hip replacement, primary knee replacement, and lumbar spine surgery. Intended user population: orthopaedic surgeons who perform hip and knee replacement, and orthopaedic/neurosurgeons who perform lumbar spine surgery.

Source page: https://510kreport.com/device/K241696
Methodology: https://510kreport.com/methodology