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Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software C…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223864

by Brainlab AG

Identifiers

510(k) Number
K223864 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)

The Alignment System Cranial is a computer-assisted surgical system designed for cranial stereotactic procedures, including biopsy and subdural electrode grid (sEEG) placement. It integrates image-guided surgery (IGS) technology with robotic or manual positioning devices to plan and execute precise trajectories for neurosurgical interventions. The system leverages alignment software to enhance accuracy and workflow efficiency during cranial interventions. Device types include robotic-assisted alignment tools and software-based trajectory planning solutions for cranial applications.

The system comprises an IGS platform (computer, touch display, infrared camera), alignment software, and positioning devices such as the Cirq Arm System or Varioguide. It is intended for use in operating rooms during neurosurgical procedures and is not described as sterile or single-use. The Cirq module is a table-mounted robotic platform, while the Varioguide provides manual alignment assistance. The device holds an FDA 510(k) clearance under the Neurology advisory committee, with the product code HAW and K-number K223864.

Frequently asked questions

What types of neurosurgical procedures is this system specifically designed to assist with in the operating room?

This system is designed to assist with cranial stereotactic procedures, including biopsy and the placement of subdural electrode grids (sEEG). It integrates image-guided surgery (IGS) technology with robotic or manual tools to plan and execute precise trajectories during these interventions, improving accuracy and workflow efficiency.

How is the Alignment System Cranial supplied, and what components are included in the setup?

The system includes an IGS platform (computer, touch display, and infrared camera), alignment software, and positioning devices such as the Cirq Arm System (a table-mounted robotic platform) or the Varioguide (a manual alignment tool). These components work together to enable precise cranial interventions during neurosurgical procedures.

Is the Alignment System Cranial intended for single-use or reusable applications, and what are the sterility considerations?

The system is not described as sterile or single-use. The components, including the robotic and manual positioning devices, are designed for reuse within a clinical setting, though proper cleaning and maintenance protocols should follow manufacturer guidelines to ensure safety and performance.

What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

The Alignment System Cranial received FDA clearance through a traditional 510(k) review process, classified as substantially equivalent under the Neurology advisory committee (NE). The product code assigned is HAW, with the K-number K223864.

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: Alignment System Cranial, Alignment Software Cranial, Cirq Alignment ..., Cirq® Cranial: Robotic Surgery for Cranial Biopsies | Brainlab, Cranial Navigation: Advanced Neuronavigation | Brainlab

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brainlab AG

Sources (1)

  • FDA 510(k) K223864 24 fields · synced Sep 19, 2026