Stryker Navigation System CT-Based Hip Module Model 6007-621-000
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050615 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 CT-Based Hip Module Model 6007-621-000 is a computer-assisted surgical planning and guidance system classified as a neurological stereotaxic instrument. It integrates with CT imaging to provide intraoperative navigation for hip procedures, enhancing precision during open or percutaneous surgery.
This module is used in operating rooms for preoperative planning and real-time surgical guidance, supporting orthopaedic interventions in the hip region. Supplied as a reusable component within the broader Stryker Navigation System, it requires compatibility with CT imaging software and hardware. Authorised under FDA 510(k) clearance (K050615), it adheres to regulatory standards for neurological devices under classification HAW and regulation 882.4560.
Frequently asked questions
What types of hip procedures can the Stryker Navigation System CT-Based Hip Module assist with during surgery?
The CT-Based Hip Module is designed to support intraoperative navigation for both open and percutaneous hip procedures. It integrates with CT imaging to enhance precision during orthopaedic interventions, such as those involving hip joint replacement, fracture fixation, or other reconstructive surgeries in the hip region. The system aids in real-time guidance to improve accuracy and reduce surgical risks.
Is the Stryker Navigation System CT-Based Hip Module reusable, and what compatibility requirements does it have?
Yes, the CT-Based Hip Module is supplied as a reusable component within the broader Stryker Navigation System. It requires compatibility with CT imaging software and hardware to function effectively, ensuring seamless integration for preoperative planning and intraoperative guidance during hip surgeries.
How is the regulatory status of this device determined, and what classification does it fall under?
The device is classified as a neurological stereotaxic instrument under product code HAW and adheres to regulatory standards outlined in 21 CFR 882.4560. It received FDA clearance through a 510(k) submission (K050615) with a Special clearance type, determined by the Neurology (NE) Advisory Committee as substantially equivalent to a predicate device.
Where can I find more information about the manufacturer or contact details for Stryker Instruments regarding this module?
For manufacturer details, Stryker Instruments is based at 4100 E. Milham Ave., Kalamazoo, MI 49001. Contact information for inquiries can be directed to Becky Ditty, though official correspondence should follow Stryker’s standard channels for regulatory or technical support.
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 - Ct-based Hip Module, Model 6007-621-000, Stryker Navigation System - Ct-based Hip Module, Model 6007-621-000, Stryker Navigation System - Ct-based Hip Module, Model 6007-621-000 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050615 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Instruments
Sources (1)
- FDA 510(k) K050615 24 fields · synced Sep 19, 2026