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Europa Posterior Cervical Fusion Navigated Instruments

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253444

by Mirus Llc

Identifiers

510(k) Number
K253444 FDA 510(k)
FDA Product Code
OLO 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 Europa Posterior Cervical Fusion Navigated Instruments are classified as navigated surgical instruments designed for spinal fusion procedures in the posterior cervical spine. These instruments facilitate precise placement of pedicle screws and rods, enabling stabilization of the cervical and upper thoracic vertebrae. The system includes polyaxial pedicle screws, rods, and set screws, engineered to form a rigid construct for structural support. Its design aligns with navigated surgical techniques to enhance accuracy during spinal interventions.

The device is supplied as a reusable surgical instrument set, intended for use in operating rooms by orthopedic or neurosurgical teams. Components are manufactured from titanium alloy (ASTM F136) and molybdenum-rhenium alloy (ASTM F3273), ensuring compatibility with MRI-safe imaging protocols where applicable. The system is cleared under the FDA’s 510(k) pathway (K253444) as substantially equivalent to existing spinal stabilization devices. Sterility and regulatory compliance are maintained through manufacturer-controlled processes, adhering to FDA and industry standards for surgical instrumentation.

Frequently asked questions

What is the Europa Posterior Cervical Fusion Navigated Instruments used for?

The Europa Posterior Cervical Fusion Navigated Instruments are designed specifically for spinal fusion procedures in the posterior cervical spine. They assist surgeons in achieving precise placement of pedicle screws and rods, which helps stabilize the cervical and upper thoracic vertebrae. This navigated system enhances accuracy during surgery, reducing the risk of misplacement and improving outcomes for patients requiring spinal stabilization.

How is the Europa system supplied, and what materials are used?

The Europa system is supplied as a reusable surgical instrument set, intended for use in operating rooms by orthopedic or neurosurgical teams. The components are made from high-quality materials: titanium alloy (ASTM F136) and molybdenum-rhenium alloy (ASTM F3273). These materials ensure durability, compatibility with MRI-safe imaging protocols where applicable, and adherence to rigorous surgical standards.

Is the Europa system single-use or reusable?

The Europa Posterior Cervical Fusion Navigated Instruments are designed as reusable surgical instruments. They are intended for repeated use in clinical settings, provided they are properly cleaned, sterilized, and maintained according to manufacturer guidelines. Reusability aligns with cost-effective and sustainable surgical practices while ensuring compliance with FDA and industry standards.

What regulatory pathway does the Europa system follow?

The Europa system is cleared under the FDA’s 510(k) pathway, specifically under clearance number K253444. This pathway confirms that the device is substantially equivalent to existing spinal stabilization devices already on the market. The clearance was granted by the FDA’s Orthopaedic Devices Advisory Committee (OR) and adheres to strict regulatory requirements for surgical instrumentation.

Are the instruments compatible with MRI imaging?

Yes, the Europa system’s materials—titanium alloy and molybdenum-rhenium alloy—are engineered to be compatible with MRI-safe imaging protocols where applicable. This ensures that patients can undergo MRI scans post-surgery without interference from the implanted hardware, provided the specific MRI settings and protocols are followed as recommended by the manufacturer.

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: EUROPA® Posterior Cervical System - MiRus, MiRus Receives New Technology Add-on Payment (NTAP) for EUROPA ..., MEARIS™ | Publication | ntap | NTP241007BVT6M

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mirus Llc
FDA Applicant
MiRus, LLC

Sources (1)

  • FDA 510(k) K253444 24 fields · synced Oct 1, 2026