Y o u r Id e a s En g i n e e r e d t o Li f e

ISSYS LP Spinal Fixation System Surgical Guide

Y o u r Id e a s En g i n e e r e d t o Li f e

In t r o d u c t i o n ISSYS LP Sp i n a l Fixation System The foundation of the ISSYS LP Spinal Fixation System is the ISSYS LP Polyaxial Screw which incorporates a number of innovative design features. Blocker Coarse 0 buttress thread design is easy to start and helps minimize cross-threading. Saddle Pin Unique design accommodates 5.5mm, 6.0mm and 6.35mm rod diameters. Hemi-circumferential contact uniformly distributes locking forces without notching the rod. Five independent locking forces make ISSYS LP one of the stiffest and strongest systems on the market. Screw Head 6.4mm of medial-lateral translation provides the surgeon added flexibility for screw placement. Low profile design allows close proximity screw placement. Bone Screw Designed to be completely seated for added stability while maintaining full polyaxial motion. Double-lead buttress thread provides for faster insertion with exceptional purchase. Thread design engineered for optimum strength. Other Features Patent pending Screwdriver with one-step, toggle free connection. Unique instrument for one-handed rod reduction and blocker insertion. Ratcheting Torque Wrench for prescribed tightening torque. All implant components are made from Ti6Al4V. MIS compatible system. ASTM test results on file at Custom Spine

Table of Contents Pedicle Preparation 1 Screw Insertion 2 Rod Preparation 3 Blocker Insertion 4 Vertebral Body Distraction and Compression 6 Final Tightening 7 System In f o r m at i o n 8 Indications Co n t r a i n d i cat i o n s Ca u t i o n s Implants 10 In s t r u m e n t s 12

Pedicle Preparation 1 2 Upon identifying the pedicle entry point, the Pedicle Probe is used to penetrate the near cortex of the pedicle. A pathway is created with the Pedicle Probe. The Pedicle Probe is marked in 10.0mm increments to assist with depth insertion. The Rasp should be inserted into the pedicle pathway to create a recess for the ISSYS LP Polyaxial Screw. 3 4 The Pedicle Sounder is used to verify the integrity of the pedicle wall. Attach the appropriate diameter Tap to the Ratchet Round Handle to prepare the canal for screw insertion. The ISSYS LP is a self-tapping screw. It is recommended to tap hard bone. If tapping is necessary attach the appropriate diameter Tap (4.5mm, 5.5mm, 6.5mm, 7.5mm, 8.5mm) to the Round Ratchet Handle. The taps are calibrated in 10mm increments. 1

Screw Insertion 1 2 IMPORTANT: After determining the appropriate screw diameter, always measure the screw to ensure screw length. Attach the Screwdriver to the Ratchet Round Handle by retracting the quick coupler on the Handle. If you do not feel a positive click, gently rotate the handle. Insert the distal tip of the Screwdriver into the saddle of the screw head until the claws engage the dimples of the screw. If the Screwdriver does not engage the screw gently rotate the threaded portion of the screw. 3 4 Pinch the arm on the shaft of the Screwdriver and push down on the coupler located on proximal screwdriver shaft to secure the screw. It is always recommended to insert the pedicle screw as deep as the anatomy allows. 2

Rod Preparation 1 2 Once all pedicle screws are inserted, it is recommended that the Rod Template be used to determine the Rod length and curvature. Use the In-situ Bender or the French Bender to contour the appropriate Rod. 3 4 Once the Rod is contoured, the Rod Holder is used to insert the Rod. The Rod Holder functions two ways; the Rod Holder may clamp down on the shaft of the rod. The rod may be inserted by connecting the pins of the rod holder. This is particularly useful when using a Minimally Invasive Surgical approach. 3

Blocker Insertion The ISSYS LP offers two options for Blocker insertion: Option 1: Option 2: 1 1 Attach the Blocker Inserter to the Round Ratchet Handle. 2 TIP: In either option, make sure the rod is fully seated in the screw head before attempting to insert the Blocker. This will help avoid false locking or cross-threading. The Rod Reducer may be used when additional force is needed to bring the Screw Head up to the Rod. 2 If the rod is slightly proud with respect to the screw head, the Rocker can be used to lever the Rod into the Screw Head Saddle. The Rocker can be aligned into the holes on the side of the Screw Head and rotated back which will lever the rod into position. 3 Prior to inserting the rod reducer over the Screw Head, the instrument must be completely opened. In position 0 the Rod Reducer is completely open and inserted over the Screw Head until the tangs on the distal tip of the Rod Reducer engage the grooves on the side of the Screw Head. With the Rocker in place, the Blocker is inserted with the Blocker Inserter until snug. At this point the blocker is ready for final-tightening. Do not over tighten the Blocker Inserter. See Final Tightening. 4

3 4 Rotate the knob clockwise to position 1. The Rod Reducer is now firmly locked to the screw head. 5 Rotate the knob clockwise to position 2 for full reduction. At this point, the rod is now optimally seated and the instrument is ready to accept the Blocker. 6 Load the Blocker onto the Blocker inserter and insert through the cannula of the Rod Reducer. Advance the Blocker until the bottom of the knurl on the Blocker Inserter is aligned with the top edge of the Rod Reducer. 7 8 At this point the Blocker is ready for final-tightening. See Final Tightening. The rod reducer must be completely opened prior to removal by rotating the knob counter clockwise to position 0. At this point, the Rod Reducer can easily be lifted from the screw head. 5

Vertebral Body Distraction and Compression DISTRACTION The ISSYS LP Distractor and Compressor will allow the surgeon to control and apply distraction and compression to the vertebral bodies. To achieve distraction, one of the Blockers is tightened while the adjacent level Blocker is not tightened. The Distractor is placed onto the Rod between the screw heads and distraction is achieved by squeezing the Distraction Handles. COMPRESSION To achieve compression, one of the Blockers is tightened, while the adjacent level Blocker is not tightened. The Compressor is placed onto the Rod outside the screw heads and compression is achieved by squeezing the Compressor Handles. The Blocker is then tightened while maintaining distraction. Final Tightening is achieved using the Counter-Torque Wrench and Torque Wrench. See Final Tightening. The Blocker is then tightened while maintaining distraction. Final Tightening is achieved using the Counter-Torque Wrench and Torque Wrench. See Final Tightening. 6

Final Tightening 1 The Torque Wrench has four groups of three arrows located around the top of the instrument, which provide visual assistance for determining the prescribed tightening torque. Prior to applying leverage, the top arrow in each group will be aligned with the bottom right arrow. Apply leverage until the top arrow is aligned with the bottom left arrow. Once the two said arrows are aligned, the prescribed tightening torque has been applied to the Blocker. NOTE: Exceeding the prescribed tightening torque by over levering the arrows past the final alignment can damage the implant and or instrument. 7

System Information NON STERILE PRODUCT The Custom Spine ISSYS LP Spinal Fixation System is comprised of spinal implants for fixation of the non-cervical spine. This includes: rods, screws and blockers. The components are manufactured from titanium alloy. The screws are available in various sizes from 4.5mm to 10.0mm diameters with lengths ranging from 25mm to 100mm. MATERIALS Titanium alloy: Ti6-Al-4V according to ISO 5832-3, ASTM F-136 (NOTE: Titanium and stainless steel implants should not be mixed in patients as corrosion may occur resulting in decreased mechanical performance) INDICATIONS The FDA regulation restricts the use of pedicle screw fixation as follows: For pedicular use: When used as a pedicle screw fixation system of the non- cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used as non pedicular fixation system: The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacraliliac screw fixation system are indicated for the following: Degenerative disc disease (DDD) of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Spondylolisthesis Fracture Spinal deformities such as scoliosis, kyphosis, lordosis Tumor Revision of failed fusion attempts Pseudarthrosis Spinal stenosis When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine. In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass. 8

Contraindications Contraindications may be relative or absolute. The choice of a particular device must be carefully weighed against the patient s overall evaluation. Circumstances listed below may reduce the chances of a successful outcome: Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis. Insufficient quality or quantity of bone which would inhibit rigid device fixation. Previous history of infection. Excessive local inflammation. Open wounds. Any neuromuscular deficit which places an unusually heavy load on the device during the healing period. Obesity. An overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself. Patients having inadequate tissue coverage of the operative site. Pregnancy. A condition of senility, mental illness, or substance abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the implant, leading to failure or other complications. Other medical or surgical conditions which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count. These contraindications can be relative or absolute and must be taken into account by the physician when making his decision. The above list is not exhaustive. CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a licensed physician. Pedicle Screw implantation should only be performed by experienced spinal surgeons with specific training in the use of the ISSYS LP Spinal Fixation System. This is a technically demanding procedure with a risk of serious patient injury. The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture dislocation, scoliosis, kyphosis, spinal tumor, and failed pervious fusion. (Pseudoarthrosis) The safety and effectiveness of these devices for any other conditions are unknown. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation. 9

Implants Catalog # Description Notes 043000 ISSYS LP Blocker Screw 046040 ISSYS LP Spinal Rod 6.0x40 046050 ISSYS LP Spinal Rod 6.0x50 046060 ISSYS LP Spinal Rod 6.0x60 046070 ISSYS LP Spinal Rod 6.0x70 046080 ISSYS LP Spinal Rod 6.0x80 046090 ISSYS LP Spinal Rod 6.0x90 046100 ISSYS LP Spinal Rod 6.0x100 046110 ISSYS LP Spinal Rod 6.0x110 046120 ISSYS LP Spinal Rod 6.0x120 046200 ISSYS LP Spinal Rod 6.0x200 046400 ISSYS LP Spinal Rod 6.0x400 046600 ISSYS LP Spinal Rod 6.0x600 047040 ISSYS LP Spinal Rod 6.35x40 047050 ISSYS LP Spinal Rod 6.35x50 047060 ISSYS LP Spinal Rod 6.35x60 047070 ISSYS LP Spinal Rod 6.35x70 047080 ISSYS LP Spinal Rod 6.35x80 047090 ISSYS LP Spinal Rod 6.35x90 047100 ISSYS LP Spinal Rod 6.35x100 047110 ISSYS LP Spinal Rod 6.35x110 047120 ISSYS LP Spinal Rod 6.35x120 047200 ISSYS LP Spinal Rod 6.35x200 047400 ISSYS LP Spinal Rod 6.35x400 047600 ISSYS LP Spinal Rod 6.35x600 Pre-bent Straight Pre-bent Straight 10

044525 ISSYS LP Spinal Screw Polyaxial 4.5x25 044530 ISSYS LP Spinal Screw Polyaxial 4.5x30 044535 ISSYS LP Spinal Screw Polyaxial 4.5x35 044540 ISSYS LP Spinal Screw Polyaxial 4.5x40 044545 ISSYS LP Spinal Screw Polyaxial 4.5x45 044550 ISSYS LP Spinal Screw Polyaxial 4.5x50 045530 ISSYS LP Spinal Screw Polyaxial 5.5x30 045535 ISSYS LP Spinal Screw Polyaxial 5.5x35 045540 ISSYS LP Spinal Screw Polyaxial 5.5x40 045545 ISSYS LP Spinal Screw Polyaxial 5.5x45 045550 ISSYS LP Spinal Screw Polyaxial 5.5x50 046530 ISSYS LP Spinal Screw Polyaxial 6.5x30 046535 ISSYS LP Spinal Screw Polyaxial 6.5x35 046540 ISSYS LP Spinal Screw Polyaxial 6.5x40 046545 ISSYS LP Spinal Screw Polyaxial 6.5x45 046550 ISSYS LP Spinal Screw Polyaxial 6.5x50 046555 ISSYS LP Spinal Screw Polyaxial 6.5x55 047535 ISSYS LP Spinal Screw Polyaxial 7.5x35 047540 ISSYS LP Spinal Screw Polyaxial 7.5x40 047545 ISSYS LP Spinal Screw Polyaxial 7.5x45 047550 ISSYS LP Spinal Screw Polyaxial 7.5x50 047555 ISSYS LP Spinal Screw Polyaxial 7.5x55 047560 ISSYS LP Spinal Screw Polyaxial 7.5x60 047580 ISSYS LP Spinal Screw Polyaxial 7.5x80 048540 ISSYS LP Spinal Screw Polyaxial 8.5x40 048550 ISSYS LP Spinal Screw Polyaxial 8.5x50 048560 ISSYS LP Spinal Screw Polyaxial 8.5x60 048580 ISSYS LP Spinal Screw Polyaxial 8.5x80 Non self-tapping Self-tapping 4.5mm 5.5mm 6.5mm 7.5mm 8.5mm 11

Instrument Overview Catalog # Description 049000 Rasp 049001 Pedicle Probe 049002 5.5mm Tap 049003 6.5mm Tap 049004 7.5mm Tap 049005 8.5mm Tap 049006 Screwdriver 049007 Rod Holder 049008 Rod Pusher 049009L 049009R In-situ Bender Left In-situ Bender Right 049010 Compressor 12

049011 Distractor 049012 Blocker Inserter 049013 Counter-Torque Wrench 049014 Revision Driver 049015 Torque Wrench 019001N Narrow Pedicle Probe 019002 Pedicle Sounder 019004 4.5mm Tap 019009SR Ratchet Handle 019012 Rod Template 13

049017 Rod Reducer 049016 Cam-Coupler 019016 Rocker 019017 Rod Gripper 019018 French Bender 019029 Tap Sleeve 14

Tel: (973) 808-0019 Fa x: (973) 808-0707 1140 Parsippany Blvd., Suite 201 Pa r s i p pa n y, NJ 07054 www.customspine.com Product Number: 000201 REV A