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Silony Medical VERTICALE Manual

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VERTICALE
Navigation
®
INSTRUMENTATION GUIDE

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Summary of Contents for Silony Medical VERTICALE

  • Page 1 VERTICALE Navigation ® INSTRUMENTATION GUIDE...

  • Page 2: Table Of Contents

    The Navigation tracker shown in this instrumentation guide is representative for a variety of general navigation tracker customary in the market� NOTE: The following guide is intended to familiarize you with the surgical procedure and use of the VERTICALE® Navigation Instrumentation� This instrumentation guide supplements the guides for the VERTICALE® Screw Rod System�...

  • Page 3: Introduction / Preface

    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®...

  • Page 4: Preparation Of Navigation System And Instrumentation

    If the respective third-party instrument tracker set is not available at the hospital, the VERTICALE® Navigation Instruments cannot be navigated� In the event that the respective third-party instrument tracker set is unavailable, a non-navigated technique using fluoroscopy and respective Silony Medical instrumentation may be adopted as per Silony Medical Instrumentation guides�...

  • Page 5: Assembly Of Instruments

    3) Additional steps for Navigated Screw Driver The Navigated screw driver consists of a navigated driver shaft in combination with modular components of the VERTICALE® Screw driver VI-1130� Please refer to the instrument list section at the end of this guide for combination options, e�g�...

  • Page 6: Instrument Registration Instructions

    Use the cross-reference table at the end of this guide for any VERTICALE Navigation Instrument being used� Upon successful registration, the trajectory and location of the distal tip of the instrument or screw are visually represented within the software by the third-party instrument or screw selected from the corresponding tool cards�...

  • Page 7: Instrumentation / Surgical Steps

    The following section describes only the specific steps for the use of VERTICALE® Navigation instruments� For the general instrumentation steps of the VERTICALE system for an open appraoch, we ask you to study the instrumentation guide for the VERTICALE® OPEN Screw Rod system�...

  • Page 8: Position And Approach

    Position and approach Please refer to the VERTICALE® OPEN Instrumentation Guide for information on patient position and approach� Opening the cortex of the pedicle VI-7010 VERTICALE Nav Awl with Stop* Assemble and register respective awl as described in assembly and registration section� Please refer to general notes section prior to navigation�...

  • Page 9: Tapping (Optional)

    * Further instrument options at the end of this guide� Selection of screw Select the VERTICALE® pedicle screw type and size (length and diameter) based on pre-operative planning and fluoroscopic imaging� VERTICALE® Pedicle screws with short &...

  • Page 10: Screw Loading Onto Navigated Screw Driver

    3) Loading screw, in analogy to VI-1130 The VERTICALE® pedicle screw driver tip is first inserted deeply into the inner drive feature of the screw shaft� After that, the internal thread of the screw head is connected to...

  • Page 11: Screw Insertion

    Please refer to general notes section prior navigation� Please refer to the VERTICALE® OPEN Instrumentation Guide for information on inserting the pedicle screw and disengaging the screw driver�...

  • Page 12: Product Information

    VERTICALE NAVIGATION ® PRODUCT INFORMATION The following section gives an overview on compatible instruments of the VERTICALE® Screw Rod System.

  • Page 13: Instruments

    9�2 mm, can VERTICALE Nav Tap 10�2 mm, VI-7202 Solera 8�5 mm Tap 9734304 * Note: VERTICALE Screw driver options • Basic Core VI-1130�1 or VI-1131�1 or SI-0024�1 with a) Outer Sleeve VI-1130�2 or PI 02 VERTICALE NAVIGATION b) Outer Sleeve SI-0024�2...
  • Page 14 • VERTICALE® MultiLocking (D60065) • VERTICALE® MultiLocking screw The following table contains information on navigation compatible VERTICALE® pedicle screw assemblies and the associated toolcard that should be selected when that assembly is utilized in a navigation procedure� Corresponding Medtronic Toolcard...
  • Page 15 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number S-VPS-4530-S2 Ø 4�5 x 30 Polyaxial Pedicle Screw, self-tapping, solid shaft S-VPS-4530-K2 Ø 4�5 x 30 Polyaxial Pedicle Screw, self-tapping, cannulated shaft S-VPS-4530-RS3 Ø 4�5 x 30 Polyaxial Pedicle Screw, self-tapping, reduction, solid shaft S-VPS-4530-RK3 Ø...
  • Page 16 Ø4�5x45 Polyaxial Pedicle Screw, self-tapping, reduction, solid shaft Solera Ø 4�5 x 45 mm 54840004545 S-VPS-4545-RK3 Ø4�5x45 Polyaxial Pedicle Screw, self-tapping, reduction, cannulated shaft S-VFS-4545-S1 Ø4�5x45 Monoaxial Pedicle Screw, self-tapping, solid shaft S-VFS-4545-K1 Ø4�5x45 Monoaxial Pedicle Screw, self-tapping, cannulated shaft PI 05 SILONY MEDICAL – Instrumentation Guide...
  • Page 17 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number S-VFS-4545-RS2 Ø 4�5 x 45 Monoaxial Pedicle Screw, self-tapping, reduction, solid shaft S-VFS-4545-RK2 Ø 4�5 x 45 Monoaxial Pedicle Screw, self-tapping, reduction, cannulated shaft S-VUS-4545-S1 Ø 4�5 x 45 Uniplanar Pedicle Screw, solid shaft S-VUS-4545-K1 Ø...
  • Page 18 Ø 5�2 x 30 Monoaxial Pedicle Screw, self-tapping, reduction, cannulated shaft S-VUS-5230-S1 Ø 5�2 x 30 Uniplanar Pedicle Screw, solid shaft S-VUS-5230-K1 Ø 5�2 x 30 Uniplanar Pedicle Screw, cannulated shaft S-VUS-5230-RS2 Ø 5�2 x 30 Uniplanar Pedicle Screw, reduction, solid shaft PI 07 SILONY MEDICAL – Instrumentation Guide...
  • Page 19 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number S-VUS-5230-RK2 Ø 5�2 x 30 Uniplanar Pedicle Screw, reduction, cannulated shaft S-VML-5230-S2 Ø 5�2 x 30 MultiLocking Pedicle Screw, solid shaft Solera 5�5/6�0 MAS S-VML-5230-K2 Ø 5�2 x 30 MultiLocking Pedicle Screw, cannulated shaft 55840005530 Ø...
  • Page 20 Ø 5�2 x 45 MultiLocking Pedicle Screw, cannulated and fenestrated shaft S-VML-5245-RS2 Ø 5�2 x 45 MultiLocking Pedicle Screw, reduction, solid shaft S-VML-5245-RF2 Ø 5�2 x 45 MultiLocking Pedicle Screw, reduction, cannulated and fenestrated shaft PI 09 SILONY MEDICAL – Instrumentation Guide...
  • Page 21 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number S-VPS-5250-S2 Ø 5�2 x 50 Polyaxial Pedicle Screw, self-tapping, solid shaft S-VPS-5250-KF2 Ø 5�2 x 50 Polyaxial Pedicle Screw, self-tapping, cannulated and fenestrated shaft S-VPS-5250-RS3 Ø 5�2 x 50 Polyaxial Pedicle Screw, self-tapping, reduction, solid shaft Ø...
  • Page 22 Ø 6�2 x 25 Monoaxial Pedicle Screw, self-tapping, solid shaft S-VFS-6225-K1 Ø 6�2 x 25 Monoaxial Pedicle Screw, self-tapping, cannulated shaft S-VFS-6225-RS2 Ø 6�2 x 25 Monoaxial Pedicle Screw, self-tapping, reduction, solid shaft PI 11 SILONY MEDICAL – Instrumentation Guide...
  • Page 23 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number S-VFS-6225-RK2 Ø 6�2 x 25 Monoaxial Pedicle Screw, self-tapping, reduction, cannulated shaft S-VUS-6225-S1 Ø 6�2 x 25 Uniplanar Pedicle Screw, solid shaft S-VUS-6225-K1 Ø 6�2 x 25 Uniplanar Pedicle Screw, cannulated shaft S-VUS-6225-RS2 Ø...
  • Page 24 S-VML-6240-S2 Ø 6�2 x 40 MultiLocking Pedicle Screw, solid shaft S-VML-6240-KF2 Ø 6�2 x 40 MultiLocking Pedicle Screw, cannulated and fenestrated shaft S-VML-6240-RS2 Ø 6�2 x 40 MultiLocking Pedicle Screw, reduction, solid shaft PI 13 SILONY MEDICAL – Instrumentation Guide...
  • Page 25 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number Solera 5�5/6�0 MAS S-VML-6240-RF2 Ø 6�2 x 40 MultiLocking Pedicle Screw, reduction, cannulated and fenestrated shaft 55840006540 Ø 6�5 x 40 mm S-VPS-6245-S2 Ø 6�2 x 45 Polyaxial Pedicle Screw, self-tapping, solid shaft S-VPS-6245-KF2 Ø...
  • Page 26 Ø 6�2 x 60 Monoaxial Pedicle Screw, self-tapping, solid shaft S-VFS-6260-KF1 Ø 6�2 x 60 Monoaxial Pedicle Screw, self-tapping, cannulated and fenestrated shaft S-VFS-6260-RS2 Ø 6�2 x 60 Monoaxial Pedicle Screw, self-tapping, reduction, solid shaft PI 15 SILONY MEDICAL – Instrumentation Guide...
  • Page 27 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number Ø 6�2 x 60 Monoaxial Pedicle Screw, self-tapping, reduction, cannulated and S-VFS-6260-RF2 fenestrated shaft S-VUS-6260-S1 Ø 6�2 x 60 Uniplanar Pedicle Screw, solid shaft S-VUS-6260-KF1 Ø 6�2 x 60 Uniplanar Pedicle Screw, cannulated and fenestrated shaft S-VUS-6260-RS2 Ø...
  • Page 28 S-VML-7235-S2 Ø 7�2 x 35 MultiLocking Pedicle Screw, solid shaft S-VML-7235-KF2 Ø 7�2 x 35 MultiLocking Pedicle Screw, cannulated and fenestrated shaft S-VML-7235-RS2 Ø 7�2 x 35 MultiLocking Pedicle Screw, reduction, solid shaft PI 17 SILONY MEDICAL – Instrumentation Guide...
  • Page 29 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number Solera 5�5/6�0 MAS S-VML-7235-RF2 Ø 7�2 x 35 MultiLocking Pedicle Screw, reduction, cannulated and fenestrated shaft 55840007535 Ø 7�5 x 35 mm S-VPS-7240-S2 Ø 7�2 x 40 Polyaxial Pedicle Screw, self-tapping, solid shaft S-VPS-7240-KF2 Ø...
  • Page 30 Ø 7�2 x 55 Monoaxial Pedicle Screw, self-tapping, solid shaft S-VFS-7255-KF1 Ø 7�2 x 55 Monoaxial Pedicle Screw, self-tapping, cannulated and fenestrated shaft S-VFS-7255-RS2 Ø 7�2 x 55 Monoaxial Pedicle Screw, self-tapping, reduction, solid shaft PI 19 SILONY MEDICAL – Instrumentation Guide...
  • Page 31 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number Ø 7�2 x 55 Monoaxial Pedicle Screw, self-tapping, reduction, cannulated and S-VFS-7255-RF2 fenestrated shaft S-VUS-7255-S1 Ø 7�2 x 55 Uniplanar Pedicle Screw, solid shaft S-VUS-7255-KF1 Ø 7�2 x 55 Uniplanar Pedicle Screw, cannulated and fenestrated shaft S-VUS-7255-RS2 Ø...
  • Page 32 S-VML-7280-S2 Ø 7�2 x 80 MultiLocking Pedicle Screw, solid shaft S-VML-7280-KF2 Ø 7�2 x 80 MultiLocking Pedicle Screw, cannulated and fenestrated shaft S-VML-7280-RS2 Ø 7�2 x 80 MultiLocking Pedicle Screw, reduction, solid shaft PI 21 SILONY MEDICAL – Instrumentation Guide...
  • Page 33 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number Solera 5�5/6�0 MAS S-VML-7280-RF2 Ø 7�2 x 80 MultiLocking Pedicle Screw, reduction, cannulated and fenestrated shaft 55840007580 Ø 7�5 x 80 mm S-VPS-8240-S2 Ø 8�2 x 40 Polyaxial Pedicle Screw, self-tapping, solid shaft S-VPS-8240-KF2 Ø...
  • Page 34 Solera 5�5/6�0 MAS S-VPS-8270-KF2 Ø 8�2 x 70 Polyaxial Pedicle Screw, self-tapping, cannulated and fenestrated shaft 55840008570 Ø 8�5 x 70 mm S-VPS-8270-RS3 Ø 8�2 x 70 Polyaxial Pedicle Screw, self-tapping, reduction, solid shaft PI 23 SILONY MEDICAL – Instrumentation Guide...
  • Page 35 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number Ø 8�2 x 70 Polyaxial Pedicle Screw, self-tapping, reduction, cannulated and fe- S-VPS-8270-RF3 nestrated shaft S-VFS-8270-S1 Ø 8�2 x 70 Monoaxial Pedicle Screw, self-tapping, solid shaft S-VFS-8270-KF1 Ø 8�2 x 70 Monoaxial Pedicle Screw, self-tapping, cannulated and fenestrated shaft S-VFS-8270-RS2 Ø...
  • Page 36 S-VFS-9240-RF2 fenestrated shaft S-VIS-9240-S1 Ø 9�2 x 40 Iliac Screw, solid shaft S-VIS-9240-KF1 Ø 9�2 x 40 Iliac Screw, cannulated and fenestrated shaft S-VIS-9240-RS2 Ø 9�2 x 40 Iliac Screw, reduction, solid shaft PI 25 SILONY MEDICAL – Instrumentation Guide...
  • Page 37 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number Solera 5�5/6�0 MAS S-VIS-9240-RF2 Ø 9�2 x 40 Iliac Screw, reduction, cannulated and fenestrated shaft 55840009540 Ø 9�5 x 40 mm S-VPS-9245-S2 Ø 9�2 x 45 Polyaxial Pedicle Screw, self-tapping, solid shaft S-VPS-9245-KF2 Ø...
  • Page 38 Solera 5�5/6�0 MAS S-VPS-9290-KF2 Ø 9�2 x 90 Polyaxial Pedicle Screw, self-tapping, cannulated and fenestrated shaft 55840009580 Ø 9�5 x 80 mm S-VPS-9290-RS3 Ø 9�2 x 90 Polyaxial Pedicle Screw, self-tapping, reduction, solid shaft PI 27 SILONY MEDICAL – Instrumentation Guide...
  • Page 39 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number Ø 9�2 x 80 Polyaxial Pedicle Screw, self-tapping, reduction, cannulated and S-VPS-9280-RF3 fenestrated shaft S-VFS-9280-S1 Ø 9�2 x 80 Monoaxial Pedicle Screw, self-tapping, solid shaft Ø 9�2 x 80 Monoaxial Pedicle Screw, self-tapping, cannulated and fenestrated...
  • Page 40 Solera 5�5/6�0 MAS S-VPS-0250-KF2 Ø 10�2 x 50 Polyaxial Pedicle Screw, self-tapping, cannulated and fenestrated shaft 55840001550 Ø 10�5 x 50 mm S-VPS-0250-RS3 Ø 10�2 x 50 Polyaxial Pedicle Screw, self-tapping, reduction, solid shaft PI 29 SILONY MEDICAL – Instrumentation Guide...
  • Page 41 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number Ø 10�2 x 50 Polyaxial Pedicle Screw, self-tapping, reduction, cannulated and S-VPS-0250-RF3 fenestrated shaft S-VFS-0250-S1 Ø 10�2 x 50 Monoaxial Pedicle Screw, self-tapping, solid shaft Ø 10�2 x 50 Monoaxial Pedicle Screw, self-tapping, cannulated and fenestrated...
  • Page 42 Solera 5�5/6�0 MAS S-VPS-0290-KF2 Ø 10�2 x 90 Polyaxial Pedicle Screw, self-tapping, cannulated and fenestrated shaft 55840001590 Ø 10�5 x 90 mm S-VPS-0290-RS3 Ø 10�2 x 90 Polyaxial Pedicle Screw, self-tapping, reduction, solid shaft PI 31 SILONY MEDICAL – Instrumentation Guide...
  • Page 43 VERTICALE® Implants Corresponding Medtronic Toolcard Article number Description StealthStation Toolcard Part Number Ø 10�2 x 90 Polyaxial Pedicle Screw, self-tapping, reduction, cannulated and S-VPS-0290-RF3 fenestrated shaft S-VFS-0290-S1 Ø 10�2 x 90 Monoaxial Pedicle Screw, self-tapping, solid shaft Ø 10�2 x 90 Monoaxial Pedicle Screw, self-tapping, cannulated and fenestrated...
  • Page 44 Silony Medical GmbH elabeling.silony-medical.com/contact Leinfelder Straße 60 70771 Leinfelden-Echterdingen Germany Tel +49 711 78 25 25 0 Fax +49 711 78 25 25 11 www.silony-medical.com This information is only intended for the USA and its territories� 12.01.2022 D60063.a�EN...

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