# K261352: 2D Hip Planning Software

- Pathway: 510(k) (Traditional)
- Applicant: One Ortho
- Decided: Jun 8, 2026 after 45 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160001: TraumaCad Mobile Release 2.0, Voyant Health, Ltd. (2016) Summary page 5.

## Indications for use
The 2D HIP PLANNING SOFTWARE is indicated for assisting orthopedic surgeons in preoperative planning of primary hip replacement orthopedic surgery. The device allows for overlaying prosthesis templates on radiological images and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation.

Source page: https://510kreport.com/device/K261352
Methodology: https://510kreport.com/methodology