Stryker Navigation System - Cranial Module, Model 6000-650-000
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062640 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 Stryker Navigation System - Cranial Module, Model 6000-650-000 is a Neurological Stereotaxic Instrument designed for computer-assisted cranial surgery. It provides pre-operative planning and intraoperative guidance by utilizing wireless optical tracking to localize surgical instruments relative to rigid anatomical structures, integrating medical imaging for precise navigation.
This system is intended for use in operating rooms and requires sterile or aseptic conditions for cranial procedures. Supplied as a reusable medical device, it incorporates multi-modality image correlation and automated brain surface segmentation. Authorized under FDA 510(k) clearance (K062640), it adheres to regulatory standards for neurological instruments, with no specific MRI safety restrictions noted in available data.
Frequently asked questions
What types of cranial surgeries is this navigation system designed to assist with, and how does it work in the operating room?
The Stryker Navigation System - Cranial Module (Model 6000-650-000) is designed for computer-assisted cranial surgery, enabling precise localization of surgical instruments relative to rigid anatomical structures. It uses wireless optical tracking combined with pre-operative medical imaging (such as CT or MRI scans) to guide procedures in real-time. This helps surgeons perform tasks like biopsies, tumor resections, or deep brain stimulator placements with enhanced accuracy, particularly in complex or minimally invasive cases.
Is this device reusable, and if so, what considerations should be taken for its maintenance and sterilization?
Yes, the Stryker Navigation System - Cranial Module is supplied as a reusable medical device. Since it is intended for use in sterile or aseptic conditions during cranial procedures, it must undergo proper cleaning, disinfection, and sterilization between uses to maintain functionality and prevent contamination. Follow manufacturer guidelines for maintenance to ensure optimal performance and compliance with regulatory standards.
What regulatory pathway was followed for this device’s clearance, and which advisory committee was involved?
The Stryker Navigation System - Cranial Module received FDA clearance through a Traditional 510(k) pathway, determined to be *substantially equivalent* to a predicate device. The review was conducted under the Neurology (NE) advisory committee, which evaluates neurological instruments like this one. The clearance number is K062640, filed in 2006 and decided in December of the same year.
Are there any MRI safety restrictions for this device when used in conjunction with imaging during surgery?
The available data for this device does not specify any MRI safety restrictions, meaning it may be compatible for use in MRI-equipped operating rooms. However, always verify compatibility with the specific MRI system in use and follow the manufacturer’s instructions to ensure safe integration during cranial 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: Stryker Navigation System - Cranial Module, Model 6000-650-000, STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL… - FDA.report, PDF K062640 - Stryker Navigation System - Cranial Module, Model 6000-650-000
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062640 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Instruments
Sources (1)
- FDA 510(k) K062640 24 fields · synced Sep 18, 2026