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Modus Nav

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183325

by Synaptive Medical Inc

Identifiers

510(k) Number
K183325 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 Modus Nav is a Computer-Assisted Surgical Navigation System (HAW classification) designed to provide real-time, image-guided visualization for neurosurgical procedures. It integrates with imaging data to assist surgeons in planning and executing precise trajectories, enhancing spatial orientation during cranial and spinal interventions.

This system is intended for use in operating rooms and is supplied as a reusable, modular unit requiring installation and maintenance by qualified service personnel. It is not single-use and must comply with MRI safety standards as specified by the manufacturer. Authorized in the U.S. via FDA 510(k) clearance (K183325), it operates under traditional review with a Neurology advisory committee designation.

Frequently asked questions

What types of neurosurgical procedures is the Modus Nav designed to assist with, and how does it improve precision during surgery?

The Modus Nav is specifically designed to assist with cranial and spinal neurosurgical procedures by providing real-time, image-guided visualization. It integrates with pre-operative imaging data to help surgeons plan and execute precise trajectories, which enhances spatial orientation and reduces the risk of off-target placement during interventions.

Is the Modus Nav a single-use device, or is it intended for repeated use in multiple procedures?

The Modus Nav is a reusable, modular system intended for use across multiple procedures. It is not designed for single-use and requires installation, maintenance, and servicing by qualified personnel to ensure continued functionality and safety.

How does the Modus Nav ensure compatibility with MRI environments, and what considerations should clinicians keep in mind?

The Modus Nav is explicitly designed to comply with MRI safety standards as outlined by the manufacturer. Clinicians should follow the manufacturer’s guidelines for proper installation, use, and maintenance to ensure safe operation within MRI environments, including avoiding interference with imaging equipment.

What regulatory pathway was followed for FDA clearance of the Modus Nav, and which advisory committee was involved?

The Modus Nav received FDA clearance through a 510(k) submission under traditional review, with a designation for the Neurology (NE) advisory committee. The clearance was granted as substantially equivalent (SESE) to a predicate device, ensuring compliance with U.S. regulatory requirements for computer-assisted surgical navigation systems.

How is the Modus Nav supplied, and what kind of technical support is required for its operation?

The Modus Nav is supplied as a reusable, modular unit that must be installed and maintained by qualified service personnel. It is not a plug-and-play device, so clinicians will need to rely on the manufacturer’s technical support and trained personnel for setup, calibration, and ongoing maintenance to ensure accurate and reliable performance.

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: Modus Nav - synaptivemedical.com, PDF Modus Nav 2.1 User Manual (MAN-0655 R-B), Synaptive Medical, MODUS NAV - Synaptive Medical Inc. Trademark Registration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Synaptive Medical Inc
FDA Applicant
Synaptive Medical, Inc.

Sources (1)

  • FDA 510(k) K183325 24 fields · synced Sep 19, 2026