Navigation Sw Hip 3.1 On Ci
FDA 510(k)Class II (US FDA 510(k))
by Brainlab AG
Identifiers
- 510(k) Number
- K052213 FDA 510(k)
- FDA Product Code
- HAW FDA 510(k)
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 Neurological Stereotaxic Instrument (Product Code HAW) designed for intraoperative image-guided localization. It integrates a freehand probe with a passive marker sensor system to link physical navigation to virtual imaging environments, such as preoperative patient data processed by a VectorVision or Ci workstation, or custom 3D bone models.
The software is used in operating rooms for real-time surgical guidance, enabling precise alignment and targeting during hip procedures. Supplied as a digital download, it is classified as a Class II medical device under FDA regulation 882.4560 and holds a FDA 510(k) clearance (K052213) with a Special review classification. No sterility or single-use specifications are stated, and MRI safety is not addressed in the available data.
Frequently asked questions
What types of hip procedures is this software designed to assist with during surgery?
This software, Navigation SW HIP 3.1 ON CI, is specifically designed for intraoperative image-guided localization in hip procedures. It integrates a freehand probe with a passive marker sensor system to align physical navigation with virtual imaging environments, such as preoperative patient data processed by Brainlab’s VectorVision or Ci workstation or custom 3D bone models. This enables precise real-time surgical guidance, particularly for procedures requiring accurate targeting and alignment.
How is this software supplied, and what does that mean for its use in the operating room?
The software is supplied as a digital download, meaning it is not a physical device but rather an update or installation for compatible systems. This allows hospitals or clinics with the required hardware (such as Brainlab’s navigation workstations) to integrate it into their existing setup. Since it’s a digital product, there are no sterility concerns or single-use limitations—it can be installed and reused across multiple procedures as long as the underlying hardware remains functional.
Is this software compatible with any specific operating systems or hardware beyond what’s mentioned?
The available data does not specify compatibility beyond its integration with VectorVision or Ci workstations and the use of a freehand probe with a passive marker sensor system. For precise details on supported operating systems or additional hardware requirements, you would need to consult Brainlab’s official documentation or contact their technical support, as the software’s functionality relies on these specific systems.
What does the FDA’s Special review classification mean for this device’s approval process?
The Special review classification assigned by the FDA indicates that this device underwent a more rigorous evaluation than standard 510(k) submissions. This typically involves additional scrutiny by the Neurology (NE) advisory committee to ensure the device’s safety and effectiveness, particularly for its intended use in intraoperative image-guided localization. The classification does not change the device’s intended purpose but reflects the complexity or innovation of the technology.
Are there any storage requirements or considerations for this software after installation?
Since this is a digital download, storage requirements depend on the workstation’s hardware specifications rather than the software itself. However, to ensure optimal performance and compatibility, the workstation must meet Brainlab’s system requirements for the VectorVision or Ci platform. There are no explicit storage conditions (e.g., temperature or humidity) mentioned for the software alone, but standard IT practices for medical device software—such as regular backups and system updates—should be followed to maintain functionality.
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 SW HIP 3.1 ON CI (K052213) — FDA 510(k) | Innolitics, NAVIGATION SW HIP 3.1 ON CI 510(k) K052213 - FDA.report, PDF 510 (k) Summary of Safety and Effectiveness for VectorVision® hi
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052213 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA 510(k) K052213 24 fields · synced Sep 19, 2026