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HipEOS

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161479

by Onefit Medical

Identifiers

510(k) Number
K161479 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The HipEOS is a Class II X-ray system used in radiology for pre-operative surgical planning for hip replacement. It features an extensive library of digital 3D models of implants from leading manufacturers, allowing for the overlay of 3D/2D implant models on radiological images and 3D reconstruction.

The HipEOS is supplied with a program that permits the selection of appropriate size and position of implants. It is a Special 510K cleared device, classified as a System, Image Processing, Radiological, with authorizations including FDA 510K. The device has been cleared by the FDA, with the most recent clearance in 2018.

Frequently asked questions

What is the HipEOS system used for?

The HipEOS is a Class II X-ray system designed for pre-operative surgical planning in hip replacement procedures. It allows clinicians to overlay 3D/2D implant models on radiological images and perform 3D reconstructions for better surgical planning.

How is the HipEOS supplied and what software does it include?

The HipEOS is supplied with a specialized program that enables the selection of appropriate implant sizes and positions. This software includes an extensive library of digital 3D models from various implant manufacturers to assist in surgical planning.

What is the regulatory status of the HipEOS device?

The HipEOS is a Special 510K cleared device classified as a System, Image Processing, Radiological. It has been cleared by the FDA with the most recent clearance in 2018, with the K-number K161479.

Can the HipEOS be reused or is it single-use?

The device information does not specify whether the HipEOS is single-use or reusable. As a Class II X-ray system, it is likely designed for multiple uses in a clinical setting, but specific reuse instructions would be provided in the device's labeling.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Onefit hipEOS - allmed.wiki, ONEFIT MEDICAL 2.5 hipEOS - RevMed, hipEOS (K173390) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Onefit Medical

Sources (1)

  • FDA 510(k) K161479 24 fields · synced Sep 26, 2026