# K161479: hipEOS

- Pathway: 510(k) (Special)
- Applicant: Onefit Medical
- Decided: Jun 28, 2016 after 28 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: 9 generations back to K896095 (1990). 22 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142671: Onefit Hip Planner, Onefit Medical (2014) Summary page 4.

## Most influential descendants
- K173390: hipEOS (2018), 8 descendants of its own
- K212040: RI.Hip Modeler (2022), 3 descendants of its own
- K192656: Optimized Positioning System (OPS) Insight (2020), 3 descendants of its own
- K242272: CORIOGRAPH Pre-Op Planning and Modeling Services (2024), 1 descendant of its own
- K250921: CORIOGRAPH Pre-Op Planning and Modeling Services (2025), 0 descendants of its own

## Indications for use
hipEOS is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and 3D model of bones and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.

Source page: https://510kreport.com/device/K161479
Methodology: https://510kreport.com/methodology