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NAVIGATION SOFTWARE HIP-UNIVERSAL - Navigation Software Hip-Universal

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K122011

by Brainlab AG

Identifiers

510(k) Number
K122011 FDA 510(k)
FDA Product Code
OLO FDA 510(k)
Models / Variants
Navigation Software Hip-Universal FDA 510(k)EUDAMED
Navigation Software Hip Thr-Aesculap FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a navigation software system for intraoperative image-guided localization, designed specifically for total hip replacement (THR) procedures. It integrates a freehand probe with a passive marker sensor system to link physical measurements with virtual preoperative imaging data processed on Brainlab IGS platforms, enabling precise surgical planning and execution.

The software is supplied as a digital tool for use in operating rooms, interfacing with Brainlab’s image-guided surgery (IGS) platforms. It is intended for single-use within the context of THR procedures and requires compatibility with MRI-safe tracking systems. Authorised under FDA 510(k) clearance (K122011) and MDR compliance, it is not classified as sterile or reusable but is regulated as a Class II medical device under the OLO product code.

Frequently asked questions

What types of hip replacement surgeries is this navigation software designed to assist with, and how does it work during the procedure?

This software is specifically designed for total hip replacement (THR) procedures only. It integrates a freehand probe with a passive marker sensor system to link real-time physical measurements with virtual preoperative imaging data. By processing these inputs on Brainlab’s image-guided surgery (IGS) platforms, the system enables precise intraoperative localization, helping surgeons align implants accurately during surgery.

Is this software reusable, or is it intended for single-use in one procedure?

The software is intended for single-use within the context of a THR procedure. While the software itself is not a physical consumable, its application is tied to a single surgical case, as it relies on preoperative imaging and intraoperative data specific to that patient’s anatomy.

Does this navigation software require any special equipment or compatibility with other devices to function?

Yes, this software requires compatibility with Brainlab’s image-guided surgery (IGS) platforms for processing and visualization. Additionally, it must be used with an MRI-safe tracking system to ensure accurate freehand probe and passive marker sensor functionality during surgery.

How is this software supplied, and what should I consider when storing it?

The software is supplied as a digital tool—it is not a physical device but rather an application installed on Brainlab’s IGS platforms. Since it is not sterile or reusable, storage considerations focus on ensuring the operating room’s IGS system remains updated and functional for use in THR procedures. No specific environmental storage conditions (like temperature or humidity) are mentioned, but standard IT infrastructure requirements for medical software should be followed.

What regulatory approvals does this software have, and how does that affect its use?

This software holds FDA 510(k) clearance (K122011) and is compliant with the EU Medical Device Regulation (MDR). It is classified as a Class II medical device under the OLO product code, meaning it is subject to stricter regulatory oversight but does not require sterile processing or reuse. The approvals confirm its safety and effectiveness for intraoperative image-guided localization in THR procedures.

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: Navigation Software Hip-universal; Navigation Software Hip Thr-aesculap ..., Navigation Software Hip-universal; Navigation Software Hip Thr-aesculap ..., Navigation Software Hip-universal; Navigation Software Hip Thr-aesculap ..., K122011 FDA 510 (k) - NAVIGATION SOFTWARE HIP-UNIVERSAL

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brainlab AG

Sources (2)

  • FDA 510(k) K122011 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026