# K161828: kneeEOS

- Pathway: 510(k) (Traditional)
- Applicant: Onefit Medical
- Decided: Oct 3, 2016 after 90 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: 8 generations back to K896095 (1990). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073714: Traumacad Version 2.0, Orthocrat, Ltd. (2008) Summary page 4.

## Most influential descendants
- K183544: Efficient Care 3D Planning (2019), 1 descendant of its own
- K202487: HealthJOINT (2020), 0 descendants of its own

## Indications for use
kneeEOS is a software indicated for assisting orthopedic surgeon in preoperative planning of knee orthopedic surgery. The software allows for overlaying of 3D/2D implants models on radiological images EOS based and 3D reconstruction of bones, and includes tools for performing measurements on the images or 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/K161828
Methodology: https://510kreport.com/methodology