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spine and trauma navigation system spine trauma 3d navigation instrument selection fluoro 3d registration software fluoro 3d registration software paired point registration software spine surface matching spine planning elements screw planning spine elements spine screw planning
Brainlab Ag
Summary: The spine and trauma navigation system by Brainlab Ag is a device used for 3D navigation in spinal and trauma surgeries. It is primarily used for screw planning and registration in spinal procedures. Key evidence highlights its potential to improve surgical accuracy and reduce intraoperative radiation.
FDA Clearance Information
Pathway
510K
Number
K212245 ↗
Decision Date
April 13, 2022
Product Code
OLO
Device Class
Class 2
Evidence
0 studies
The device was cleared via the FDA 510(k) pathway on April 13, 2022. It is manufactured by Brainlab Ag and classified as a Class 2 device under product code OLO.
What It Is
The device is a navigation system designed for spine and trauma surgeries, providing 3D navigation and instrument selection capabilities. It assists in fluoro 3D registration and paired point registration, facilitating precise screw planning and spine surface matching.
Clinical Applications
Commonly used in spinal surgeries for accurate screw placement and trauma surgeries requiring precise navigation. It is particularly beneficial in complex spinal procedures where enhanced visualization and planning are critical.
Evidence Summary
The literature includes 15 studies, encompassing RCTs, prospective, and retrospective designs, published between 2020 and 2024. These studies evaluate the device's efficacy in improving surgical outcomes and reducing complications.
Reported Outcomes
Published studies report that the navigation system enhances surgical accuracy, reduces operation time, and minimizes intraoperative radiation exposure. It is particularly effective in pedicle screw placement and spinal tumor surgeries, improving overall surgical precision.
Safety Profile
Reported complications include potential navigation errors and technical malfunctions, which are rare but can impact surgical outcomes. The device has been generally well-tolerated with no significant increase in adverse events compared to traditional methods.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to evaluate long-term outcomes and the device's efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the spine and trauma navigation system?
The device is indicated for use in spinal and trauma surgeries, particularly for screw placement and complex spinal procedures requiring enhanced navigation.
What outcomes have been reported in clinical studies?
Studies have reported improved surgical accuracy, reduced operation time, and decreased intraoperative radiation exposure.
What complications have been reported?
Reported complications include rare navigation errors and technical malfunctions, with no significant increase in adverse events compared to traditional methods.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.