VERTICALE® Navigation Instruments
Silony Medical GmbHThe VERTICALE® Navigation Instruments are surgical tools designed to help surgeons accurately locate anatomical landmarks during spinal surgeries, especially in minimally invasive procedures. They work with third-party surgical navigation software that uses imaging like CT or MR scans, improving surgical precision and patient outcomes.
Intended Use
The VERTICALE® Navigation Instruments are indicated for use during the preparation and insertion of VERTICALE® and VERTICALE® CERVICAL screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with third party stereotactic navigation systems software which are indicated for any medical condition in which the use of stereotactic surgery is suitable, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized orientation points of the anatomy.
Technology
Reusable surgical instruments made of stainless steel including drill, tap, awl, driver, probe, and depth stops. Instruments are compatible with third party stereotactic navigation platforms (Medtronic StealthStation™, Brainlab, or 7D) via universal adapters allowing tracking array connection. They use CT, MR, and fluoroscopy images for navigation guidance.
Performance
Non-clinical performance testing included single point accuracy, rotation accuracy, distance accuracy, target registration error testing, and tool reflectivity testing per ASTM F2554-22 standards. Testing demonstrated sufficient strength and accuracy, supporting safety and efficacy, and substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
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