Cranial Map Neuro

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K131214 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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• Stryker NAV3I Platform

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• What is the CranialMap Neuro used for?

  The CranialMap Neuro is a Computer-Assisted Surgery System designed specifically for cranial surgical navigation. It provides intraoperative guidance and planning support during open or percutaneous neurosurgical procedures. By integrating with a dedicated computer workstation, it enables real-time tracking of surgical instruments and anatomical landmarks, enhancing accuracy and reducing risks during complex cranial interventions. Its software module also allows for pre-operative planning and intra-operative adjustments, ensuring safer and more controlled surgical outcomes.

• How is the CranialMap Neuro supplied and what does it require?

  The CranialMap Neuro is supplied as part of the Stryker Navigation System. To function, it requires integration with the Stryker Navigation Platform, Smart Instruments, and compatible accessories. The system is not standalone; it relies on these components to deliver its navigation capabilities. Additionally, it must be used in sterile environments during surgery, as it is intended for clinical procedures where sterility is critical.

• Is the CranialMap Neuro single-use or reusable?

  The CranialMap Neuro system itself is not single-use or reusable in its entirety. Instead, its usability depends on the specific instruments and accessories used within the system. Some components may be single-use, while others, like the software and certain hardware modules, can be reused across multiple procedures. The software may also receive updates over time, allowing for continued functionality with newer procedural requirements.

• Can the CranialMap Neuro be used in MRI environments?

  No, the CranialMap Neuro is explicitly stated as not MRI-compatible. This means it should not be used in or near MRI machines, as the electromagnetic fields generated by MRI systems can interfere with the system’s functionality or pose safety risks. Always ensure the operating environment adheres to the system’s specified compatibility guidelines.

• What regulatory approval does the CranialMap Neuro hold?

  The CranialMap Neuro holds FDA 510(k) clearance under the reference number K131214. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and meets the regulatory standards for computer-assisted surgical navigation in cranial procedures. The system adheres to guidelines set by the FDA for its intended use.