Navbit Sprint System – Supine Registration, Navbit Sprint Kit – Lateral Registration

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

510(k) Number

K200376 ↗

FDA Product Code

OLO

FDA applicant

Navbit Pty, Ltd.

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Navbit MARQ Lateral

  Class IIa

  CE/MDR

• Navbit MARQ Supine

  Class IIa

  CE/MDR

• Navbit Rapid Surgical Plan

  Class IIa

  FDA 510(k) K243447 Active Cleared 5 Dec 2024 CE/MDR

• What types of neurosurgical procedures is the Navbit Sprint System primarily designed to assist with, and how does it improve accuracy during these procedures?

  The Navbit Sprint System is designed to assist with deep brain stimulation, functional neurosurgery, and tumor resection by providing precise intraoperative localization and alignment. It combines supine and lateral registration capabilities, which enhance spatial accuracy by enabling real-time tracking of instruments and anatomical landmarks. This dual-registration approach helps reduce errors during complex procedures where positioning and alignment are critical.

• Is the Navbit Sprint System reusable, and if so, what considerations should be taken into account for its maintenance and sterilization?

  Yes, the Navbit Sprint System is supplied as a reusable medical device, consisting of both hardware and software components. Since it is intended for use in sterile operating room environments, proper cleaning, calibration, and maintenance are essential to preserve its functionality and accuracy. The manufacturer provides guidelines for storage and handling to ensure the device remains calibrated and ready for use, particularly given its reliance on precise intraoperative navigation.

• What regulatory pathways has the Navbit Sprint System undergone, and what does this mean for its use in clinical settings?

  The Navbit Sprint System has been authorized under both FDA 510(k) clearance (K200376) and MDD compliance, indicating it meets regulatory standards for neurological navigation systems in the United States and Europe, respectively. This clearance confirms that the device has been evaluated for safety and effectiveness as a reusable neurological navigation tool, ensuring it adheres to established guidelines for intraoperative localization and alignment in neurosurgical procedures.

• Does the Navbit Sprint System require compatibility with specific types of surgical tools, and if so, what should clinicians verify before use?

  Yes, the Navbit Sprint System requires compatibility with MRI-safe surgical tools, as it is designed for use in intraoperative environments where imaging and navigation must not interfere with MRI equipment. Clinicians should verify that all instruments and tools used alongside the system are explicitly labeled as MRI-safe to avoid potential risks, such as interference or damage to the navigation system or imaging equipment.

• What are the key differences between the Navbit Sprint System’s supine and lateral registration kits, and how might a clinician choose between them?

  The Navbit Sprint System includes two registration kits: the Supine Registration and the Lateral Registration kit. The supine kit is designed for patient positioning on their back, while the lateral kit accommodates side-lying positions, which may be necessary for certain neurosurgical approaches. A clinician would choose based on the patient’s anatomy, surgical approach, and procedural requirements—such as accessing deep brain structures or tumors—where precise alignment in either supine or lateral orientation is critical for accuracy.