Self-blocking thread reduces risk of set-screw loosening. Small screw head accommodates 40 angle variation

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1 MonoPoly PRODUCT INFORMATION the Implant Designed to meet Signus high standard of quality, the MonoPoly system offers a large selection of implants: mono- and -polyaxial screws in a diverse range of sizes and shapes Color coded screws increase the ease of implant selection. The polyaxial screws can accommodate 20 angulation in every direction while providing excellent angle stability. The instrumentation accomodates all standard surgery techniques compression, distraction, and reduction even in difficult clinical situations. (Klappen außen sind nur 192 mm breit!) Large-core diameter for even transfer of the shear forces Buttress thread provides optimal purchase in the pedicle and vertebral body Self-tapping screws facilitate easy insertion Self-blocking thread reduces risk of set-screw loosening Small screw head accommodates 40 angle variation Reduction screw for low grade spondylolisthesis correction. After final tightening of the set-screws, the predefined separation lines allow the break-off tabs to be easily removed.

2 This document was written by SIGNUS technical staff and is intended only to introduce the product. Information contained within this brochure should not be construed as surgical advice or medical opinion expressed or implied by SIGNUS. Signus Medizintechnik GmbH Carl-Zeiss-Strasse Alzenau /Germany MOBIS Monoportal Approach with Bilateral Support T.L.I.F Cage phone: +49 (0) / fax: +49 (0) / info@signus-med.de web: TETRIS Bilateral Lumbar Implant Fusion Cage P.L.I.F Cage KAINOS + Exceptional Osteoconductivity Fully Resorbable Creates the right fusion SEMIAL Anatomically Adapted Solid Support A.L.I.F Cage KIMBA Self-Guiding Spacer E.L.I.F Cage ConTact High Stability Minimally Invasive A.L.I.F. Frame Plate 01/Jan 2008 v01

3 MonoPoly For Additional Posterior Stabilization Polyaxial Fixator with reduction screw FIXATOR Product information

4 TECHNICAL INFORMATIONEN MonoPoly the Concept Posterior Top-Loading Pedicle screw system for simple and complex stabilization After spinal surgery many cases require instrumentation to stabilize the spine during fusion. The MonoPoly system from SIGNUS is designed for use in the most common applications of posterior thoracolumbar stabilization. The system s Top-loading screw design facilitates simple construct assembly. Top-Loading System Simple and quick assembly 40 Screw Angulation Simplified screw positioning Minimizes need for rod bending Self-blocking thread Reduced risk of set-screw loosening Buttress thread Optimal purchase in the pedicle and vetebral body Self-tapping screw Reduced operative steps Large core diameter Even transfer of shear forces High biomechanical strength Color-Coded Screw Heads Easy identification Low profile Minimal damage to surrounding anatomical structures Ti6Al4V Proven biocompatible material Excellent MRI compatability (Klappen außen sind nur 192 mm breit!) Indications: Degenerative disc disease Lumbar stenosis Tumors Fractures Deformities and low-grade spondylolisthesis

5 MonoPoly PRODUCT INFORMATION Instruments (Klappen außen sind nur 192 mm breit!) Art. no. Instrument Sharp Probe with Softgrip Depth Gauge a Probe Straight Pedicle Sensor T-Handle Softgrip T-Handle Ratchet Tapper Shaft 4.0 mm Tapper Shaft 6.0 mm Screwdriver SW MP0004 Blade for Set-Screw 11 MP0009 Torque Wrench 12 MP0003 Anti-Torque Wrench 13 MP0008 Blade for Torque Wrench 14 MP0001 Screwdriver Polyaxial 15 MP0002 Screwdriver Monoaxial Socket Wrench SW Length Gauge Rod Bender 19 MP0012 Persuader with Handle Rod Holder 21 MP0005 Rod Pusher 22 MP0007 Rod Fork 23 MP0010 Distractor 24 MP0011 Compressor

6 TECHNICAL INFORMATIONEN Surgical technique Screw Insertion The pedicle is prepared in the usual manner and the correct screw length is determined. The pedicle screws are inserted with the polyaxial screwdriver. The instrument design provides a simple, yet safe and secure connection between the screw and the screwdriver. Sharp Probe 1 T-Handle 5 6 Depth Gauge 2 Tapper Shaft 7 8 Probe Straight 3 Screwdriver Pedicle Sensor 4 Once the screw is inserted to the appropriate depth, the screwdriver is disconnected by turning the wing-nut counter-clockwise. Rod Placement The rod is placed into the screw head with the rod holder. If necessary, the persuader or rod fork can be used to seat the rod completely into the screw head. The rod must cover the complete width of the screw head so that the rod protrudes slightly out of the screw head at the cranial and caudal ends of the construct. With the rod placed symmetrically in and between the pedicle screws, the set-screws can be inserted and provisionally tightened. Length Gauge 17 Rod Bender 18 Rod Holder 20 Persuader 19

7 MonoPoly PRODUCT INFORMATION Compression and Distraction Prior to compressing or distracting a vertebral segment, one of the set-screws should be loosened slightly. The set-screw is re-tightened to lock the construct in the corrected position. It is important that the Compressor/ Distractor engages the screw head and not the set-screw. T-Handle 5 6 Distractor 23 Blade 10 Compressor 24 Spondylolisthesis Correction Low-grade spondylolisthesis can be corrected with the rod fork, persuader or the reduction screw. The rod fork is placed over the rod with the tangs around the sides of the screw head. The rod is seated into the screw head by applying downward pressure on the rod fork. The persuader is employed in a similar method. When using the reduction screw, the break-off tabs are removed by using the rod holder after final tightening of the set-screw. T-Handle 5 6 Blade 10 Rod Fork 22 Final Tightening With the screw-rod construct in the desired position, the anti-torque instrument is placed on the screw head, and the set-screw is ened to 10 Nm with the driver and torque wrench. tight- Torque Wrench 11 Anti-Torque Wrench 12 Blade for Torque Wrench 13 note: Incorrect handling of the instrumentation used for construct assembly and correction procedures may damage the implant and/or surrounding anatomical structures. Lateral radiograph of the MonoPoly system

8 TECHNICAL INFORMATIONEN Implant Ordering Information L d L = Length d = Outer diameter Monoaxial screw Art. no. Ø (mm) Color Length (mm) Increments Polyaxial Screws (Option: monoaxial version available) MP , mm MP , mm MP , mm MP , mm Reduction Screws Polyaxial (Option: monoaxial version available) MP , mm MP , mm MP , mm MP , mm Cross Links MP MP MP mm 42 mm 50 mm Rods A A 6, mm A 6, A A 6, mm Set-screw MP Polyaxial screw Reduction screw for low grade spondylolisthesis correction Screw diameter 4,5 mm /5,5 mm /6,5 mm /7,5 mm (Klappen außen sind nur 192 mm breit!)