The Most Reliable Spinal Solution
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1 MFG : REV : 1 4CIS VANE introduces you the reliable pedicle screw The Most Reliable Spinal Solution Non-slip threaded joint Ergonomic design Wedged trapezoid thread Superior locking mechanism SEOUL OFFICE 13F, #505-14, Gasan-dong, Geumcheon-gu, Seoul Korea Tel Fax HEAD OFFICE #34-6, Keumam-ri, Seotan-myeon, Pyeongtaek, Gyeonggi-do Korea Tel Fax
2 4CIS Vane Spine System The 4CIS VANE Spine System is indicated for temporary or permanent correction and stabilization of the vertebral column from the thoracic to the sacrum with the aim of helping consolidation or bone fusion. It is designed for both posterior, sacral and anterior fixation.
3 C o n t e n t s Design Rationale _ 05 Progressive Changes Enhanced Poly-axial System VANE PEDICLE SCREW SYSTEM Poly-Axial Screw Head & Nut Thread Poly-Axial Head Thread Poly-Axial Pedicle Screw Poly-Axial Screw Thread MECHANICAL TESTING Static Compressive test Static Tensional test Static Torsional test Dynamic Compressive test Surgical Technique _ 11 Pedicle Identification Pedicle Preparation Screw Insertion Rod Insertion Nut Application Compression / Distraction Final Tightening Cross Link Technique Case Studies _ 21 Preoperation & Postoperation Product Information _ 27 Implants Specifications Instruments Specifications Design Rationale Progressive Changes Enhanced Poly-Axial System VANE PEDICLE SCREW SYSTEM Poly-Axial Screw Head & Nut Thread Poly-Axial Head Thread Poly-Axial Pedicle Screw Poly-Axial Screw Thread MECHANICAL TESTING Static Compressive test Static Tensional test Static Torsional test Dynamic Compressive test 04 4CIS Vane Spine System V A N E S P I N E S Y S T E M
4 Design Rationale Vane Pedicle Screw System Progressive Changes 4CIS VANE Spine System is an enhanced Poly-Axial Pedicle Screw System that provides the greatest holding power on the Poly-Axial Screw housing and the Vane set Screw, and allows stability of the spinal fixation system in surgical management of the spine. Poly-Axial Screw Head & Nut Thread The design of Vane thread in the nut makes it possible to achieve firm and stable fixation between the Screw and the Nut (significantly increasing the compression strength). Enhanced Poly-axial System Superior locking performance Conic tapper housing increased stability Micro ridges on the poly-axial screw head and the washer allow maximum stability in VANE spine system Poly-Axial Head Thread Micro ridges machined in the poly-axial screw head combined with the washer incorporates a taper lock onto the poly-axial screw head allowing maximum poly-axial system stability in VANE spine system. 06 4CIS Vane Spine System 07
5 Vane Pedicle Screw System Mechanical Testing The mechanical test including static and cyclic fatigue test was performed in accordance with ASTM F1717. General thread design VANE thread design Thread Design Area Standard 0.61mm 2 Fs=50% of Fr Fs Applied the static compression bending load VANE 0.66mm 2 Fs=16% of Fr Poly-Axial Pedicle Screw Poly-Axial Pedicle Screw provides a variation of 30 in angle and ease of use while achieving best anatomic position. Poly-Axial Screw has the same profile as mono- Axial Screw in shape, height and thickness. Support Applied the static tension bending load Poly-Axial Screw Thread Various sizes of screws are available for perfect adaptation to the thoracic, lumbar and sacral pedicles. 1/3 cylinder, 2/3 cylinder and Conical Optimal stress distribution Protection from screw pullout Easy insertion Non-self tapping to minimize any neural damage. Support 08 4CIS Vane Spine System 09
6 Mechanical Testing The mechanical test including static and cyclic fatigue test was performed in accordance with ASTM F1717. Applied the static torsion bending load Support Applied the static dynamic compression bending load Surgical Technique Support Pedicle Identification Pedicle Preparation Screw Insertion Rod Insertion Nut Application Compression / Distraction Final Tightening Cross Link Technique 10 4CIS Vane Spine System V A N E S P I N E S Y S T E M
7 Surgical Technique Step 1 Surgical Technique Step 2 Pedicle Identification The pedicle entry point depends on the intersection techniques. It involves drawing a line from the lateral aspect of the facet joint, which intersects a line that bisects the transverse process at a spot overlying the pedicle. However, because of the high variability in pedicle dimensions on each level of vertebra, intraoperative radiograph is checked to determine the exact position of the entry in the anteroposterior and lateral projection after inserting guide pins. Pedicle Preparation After the determination of the pedicle entry point, the entry hole is prepared by Awl ( ). A pathway is then opened up with a Pedicle Probe ( ) from a smaller to a larger sequentially. The Pedicle Probe is calibrated and marked with 1cm intervals to help determine proper screw length. A balltipped Pedicle Tester ( ) is utilized to palpate five distinct bony borders (floor and four walls). 12 4CIS Vane Spine System 13
8 Surgical Technique Step 3 Surgical Technique Step 4 Screw Insertion With the pedicle pathway prepared and proper screw length and diameter determined, the screw is ready for insertion. Place the screw slowly while checking proper trajectory using fluoroscopic x-ray. Rod Insertion Cut the Rod to the appropriate length and bend the Rod with a French Rod Bender ( ) to fit the desired spinal contours. A Rod Holder ( ) can be used for optimal Rod insertion. 14 4CIS Vane Spine System 15
9 Surgical Technique Step 5 Surgical Technique Step 6 Nut Application After the Rod is loaded into the bottom of the screw head, the Nut may be seated onto the top of the screw head using the Nut Starter ( ). When the rod is not fully seated into the head of the screw, the Rod Introducer ( ) is preferred for reduction. The Rod Introducer is then rotated clockwise levering the Rod inside of the screw head. The Nut Starter is then used to insert the Nut. If necessary, the Rod Pusher ( ) or Anti Torque Wrench ( ) is used to hold the Rod inside of screw head. Compression or Distraction The compression or the distraction procedure may be performed if necessary. In that case, extra caution should be required when placing the nuts securely against the head of the screws. In either maneuver, the Nut on one side of the segment should be tightened provisionally, while the Nut on the other side remains loosened. The Compression or Distraction will occur against the provisionally tightened screws. 16 4CIS Vane Spine System 17
10 Surgical Technique Step 7 T-handle, square, Ratchet Final Tightening The final tightening is performed with the Nut Final Driver ( ) and the Anti Torque Wench ( ). The Anti Torque Wench is placed to a screw and a Rod, while the nut final Driver is inserted through the cannulation of the Anti Torque Wench. If necessary, the Nut Final Driver may be used to remove a nut after final tightening. Once a nut has been removed, it should be discarded and replaced with the new one. Nut Final Driver Anti Torque Wrench 18 4CIS Vane Spine System 19
11 Surgical Technique Step 8 Cross Link Technique After selection of cross link that corresponds in proper size for the distance between rods, the cross link is applied to the rods and tightened with two tightening screws. If the size of cross link doesn t fit exactly, Compressor ( ) or Distractor ( ) can be used accordingly to adjust the distance between rods before final fixation. Case Studies - Preoperation & Postoperation L5 Stenosis HIDV Isthmic Type L3-L5 Stenosis Isthmic Type L2 Fracture Isthmic Type V A N E S P I N E S Y S T E M 20 4CIS Vane Spine System
12 The 4CIS VANE Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. Post OP X-ray Product Information Implants Specifications Instruments Specifications V A N E S P I N E S Y S T E M
13 Implants Implants VANE Pedicle Screw (Mono) Mono-Axial Pedicle Screw 4.0x25mm Mono-Axial Pedicle Screw 4.0x30mm Mono-Axial Pedicle Screw 4.5x25mm Mono-Axial Pedicle Screw 4.5x30mm Mono-Axial Pedicle Screw 4.5x35mm Mono-Axial Pedicle Screw 4.5x40mm Mono-Axial Pedicle Screw 4.5x45mm Mono-Axial Pedicle Screw 4.5x50mm Mono-Axial Pedicle Screw 5.5x25mm Mono-Axial Pedicle Screw 5.5x30mm Mono-Axial Pedicle Screw 5.5x35mm Mono-Axial Pedicle Screw 5.5x40mm Mono-Axial Pedicle Screw 5.5x45mm Mono-Axial Pedicle Screw 5.5x50mm Mono-Axial Pedicle Screw 6.5x30mm Mono-Axial Pedicle Screw 6.5x35mm Mono-Axial Pedicle Screw 6.5x40mm Mono-Axial Pedicle Screw 6.5x45mm Mono-Axial Pedicle Screw 6.5x50mm Mono-Axial Pedicle Screw 6.5x55mm Mono-Axial Pedicle Screw 6.5x60mm Mono-Axial Pedicle Screw 7.5x30mm Mono-Axial Pedicle Screw 7.5x35mm Mono-Axial Pedicle Screw 7.5x40mm Mono-Axial Pedicle Screw 7.5x45mm Mono-Axial Pedicle Screw 7.5x50mm Mono-Axial Pedicle Screw 7.5x55mm Mono-Axial Pedicle Screw 7.5x60mm Mono-Axial Pedicle Screw 8.0x30mm Mono-Axial Pedicle Screw 8.0x35mm Mono-Axial Pedicle Screw 8.0x40mm Mono-Axial Pedicle Screw 8.0x45mm Mono-Axial Pedicle Screw 8.0x50mm Mono-Axial Pedicle Screw 8.0x55mm Mono-Axial Pedicle Screw 8.0x60mm Mono-Axial Pedicle Screw 8.5x30mm Mono-Axial Pedicle Screw 8.5x35mm Mono-Axial Pedicle Screw 8.5x40mm Mono-Axial Pedicle Screw 8.5x45mm Mono-Axial Pedicle Screw 8.5x50mm Mono-Axial Pedicle Screw 8.5x55mm Mono-Axial Pedicle Screw 8.5x60mm VANE Pedicle Screw (Poly) Poly-Axial Pedicle Screw 5.5x25mm Poly-Axial Pedicle Screw 5.5x30mm Poly-Axial Pedicle Screw 5.5x35mm Poly-Axial Pedicle Screw 5.5x40mm Poly-Axial Pedicle Screw 5.5x45mm Poly-Axial Pedicle Screw 5.5x50mm Poly-Axial Pedicle Screw 5.5x55mm Poly-Axial Pedicle Screw 6.5x30mm Poly-Axial Pedicle Screw 6.5x35mm Poly-Axial Pedicle Screw 6.5x40mm Poly-Axial Pedicle Screw 6.5x45mm Poly-Axial Pedicle Screw 6.5x50mm Poly-Axial Pedicle Screw 6.5x55mm Poly-Axial Pedicle Screw 6.5x60mm Poly-Axial Pedicle Screw 7.5x30mm Poly-Axial Pedicle Screw 7.5x35mm Poly-Axial Pedicle Screw 7.5x40mm Poly-Axial Pedicle Screw 7.5x45mm Poly-Axial Pedicle Screw 7.5x50mm Poly-Axial Pedicle Screw 7.5x55mm Poly-Axial Pedicle Screw 7.5x60mm VANE Nut Nut VANE Cross - Link Cross - Link 30/34mm Cross - Link 34/42mm Cross - Link 40/53mm Cross - Link 50/70mm VANE Smooth Rod Smooth Rod 5.7 x 40mm Smooth Rod 5.7 x 50mm Smooth Rod 5.7 x 60mm Smooth Rod 5.7 x 70mm Smooth Rod 5.7 x 80mm Smooth Rod 5.7 x 90mm Smooth Rod 5.7 x 100mm Smooth Rod 5.7 x 120mm Smooth Rod 5.7 x 140mm Smooth Rod 5.7 x 160mm Smooth Rod 5.7 x 180mm Smooth Rod 5.7 x 200mm Smooth Rod 5.7 x 250mm Smooth Rod 5.7 x 300mm Smooth Rod 5.7 x 350mm Smooth Rod 5.7 x 400mm Smooth Rod 5.7 x 450mm Smooth Rod 5.7 x 500mm VANE Curved Rod Curved Rod 5.7 x 40mm Curved Rod 5.7 x 50mm Curved Rod 5.7 x 60mm Curved Rod 5.7 x 70mm Curved Rod 5.7 x 80mm Curved Rod 5.7 x 90mm Curved Rod 5.7 x 100mm Curved Rod 5.7 x 120mm Curved Rod 5.7 x 140mm Curved Rod 5.7 x 160mm Curved Rod 5.7 x 180mm Curved Rod 5.7 x 200mm 28 4CIS Vane Spine System 29
14 Instruments Instruments Awl Coed No Rod Introducer Coed No Pedicle Probe for 5.5mm Screw, STR. Coed No Cross Link Screw Driver Coed No Pedicle Probe for 6.5mm Screw, STR. Coed No Guide Pin (Triangle) Coed No Guide Pin (Ellipse) Coed No Pedicle Probe for 6.5mm Screw, CVD. Coed No Tap for 5.5mm Coed No Tap for 6.5mm Coed No Pedicle Tester, STR. coed no Tap for 7.5mm Coed No Pedicle Tester, CVD. coed no Nut Starter Coed No Nut Final Driver Coed No Rod Pusher Coed No Poly Axial Bone Screw Final Driver Coed No CIS Vane Spine System 31
15 Instruments Instruments Mono Axial Screw Driver Coed No French Rod Bender Coed No Poly Axial Screw Driver Coed No Poly Axial Screw Driver Coed No Rod Gripper Coed No Torque Wrench (12N Torque Limiter) Coed No Rod Holder Coed No Poly Axial Screw Aligner Coed No In-line handle, square, Ratchet Coed No Screw Compressor Coed No T-handle, square, Ratchet Coed No Screw Distractor Coed No CIS Vane Spine System 33
16 Instruments Implants / Instruments Container Screw Tray Coed No Accessary Case Coed No Anti Torque Wrench Coed No Anti Torque Wrench Coed No Implants Container Coed No Instruments Container Coed No Nut Guide Coed No Persuader Coed No CIS Vane Spine System 35
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