# K173390: hipEOS

- Pathway: 510(k) (Traditional)
- Applicant: Onefit Medical
- Decided: Apr 27, 2018 after 179 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). 29 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161479: hipEOS, Onefit Medical (2016) Summary page 4.
- K132636: Dyonics Plan Hip Impingement Planning System, Smith & Nephew, Inc. (2013) Summary page 4.

## Most influential descendants
- 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
- K243447: Rapid Surgical Plan (RSP-SW-001) (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K173390
Methodology: https://510kreport.com/methodology