VERTICALE
NAVIGATION
3
Navigation Instruments for Silony Medical VERTICALE® Screw Rod Systems
The Navigation Instruments for VERTICALE® are designed for compatibility with the Medtronic StealthStation®
Navigation System and the Medtronic NavLock™ tracker�
For general instructions on use, indications, contraindications and warnings please refer to the following manuals and guides:
VERTICALE® OPEN and MultiLocking Screw Rod System Instrumentation Guide
Instructions for Use VERTICALE implants
Instructions for Use Silony surgical instruments
Medtronic’s current navigation system software and user guides (StealthStation®, NavLock™)
Position Verification of VERTICALE® Navigation Instruments for VERTICALE® Spine Systems has been performed with
Medtronic StealthStation® S8 Navigation System and NavLock™ Tracker�
Physicians and operators of the system, instruments and software should read all related (Silony Medical and third-party)
user guides carefully before handling the equipment and have access to the user guides at all times� Prior to using the
VERTICALE® Navigated Instruments for VERTICALE® Screw Rod Systems, the physicians and operators should review the
Silony Medical VERTICALE® System guides for their indications for use�
Silony Medical navigation instruments for VERTICALE® Screw Rod Systems are NOT compatible with the implants from
other manufacturers� The VERTICALE® Navigation Instruments are intended for use with Silony Medical VERTICALE®
implants only:
•
VERTICALE® Pedicle screws with short & reduction head
- VERTICALE® Polyaxial screw
- VERTICALE® Monoaxial screw
- VERTICALE® Uniplanar screw
- VERTICALE® Revision / Iliac screw
- VERTICALE® MultiLocking screw
INDICATIONS
/
CONTRAINDICATIONS
Please refer to the supplemental VERTICALE® system guides and Instructions for Use for general procedural instructions,
indications, contraindications and warnings�
Please consider the following additional information for Navigation use:
Additional Indications for Navigation use
Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE®
pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures�
These instruments are designed for use with third-party stereotactic navigation system Medtronic StealthStation®,
which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, 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 landmarks of the anatomy�
Additional Contraindications for Navigation use
Medical conditions which contraindicate the use of a computer-assisted surgery system and its associated applications with
Silony Medical VERTICALE® system include any medical conditions which may contraindicate the medical procedure itself�
INTRODUCTION / PREFACE
NOTE:
Please also note the Instructions for Use provided with each product� They may include additional advice that leads to
exclusion of the implant procedure�
All instrumentation guides and Instructions for Use can be found on our eLabeling portal (https://elabeling�silony-medical�com/)
