# K253551: VELYS™ Hip Navigation

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Mar 6, 2026 after 112 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: 10 generations back to K896095 (1990). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160284: JointPoint, Jointpoint, Inc. (2016) Summary page 5.

## Indications for use
VELYS™ Hip Navigation is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images. VELYS™ Hip Navigation is also indicated for assisting healthcare professionals in preoperative planning and postoperative analysis of orthopaedic surgery in Total Hip Replacement and Total Knee Replacement. The device allows for overlaying of prosthesis templates on radiological images and includes tools for performing measurements on the image and for positioning the template. Clinical jJudgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

Source page: https://510kreport.com/device/K253551
Methodology: https://510kreport.com/methodology