A U X I L I A R Y C O N N E C T O R S Surgical Technique

A U X I L I A R Y C O N N E C T O R S Surgical Technique

AUXILIARY CONNECTORS ISSYS LP Auxiliary Connectors The ISSYS LP auxiliary connectors were designed to provide medial-lateral variability for the ISSYS LP system and for revision applications. This system is intended for posterior pedicular fixation to help provide immobilization and stabilization of the posterior non cervical (T1 S1) spine. The ISSYS LP auxiliary connector system includes offset connectors and rods, as well as end to end connectors. The connectors all feature ISSYS LP s unique saddle pin design, which allows the connector to accept three rod sizes. This design provides added flexibility while reducing the need to remove the existing construct in the event of construct extension surgery. Connectors can accommodate 5.5, 6.0 and 6.35mm rods Ability to connect to existing constructs that use 5.5, 6.0 or 6.35 mm rods Connect to existing construct without screw or rod removal 2 I ISSYS LP AUXILIARY CONNECTORS SURGICAL TECHNIQUE

SURGICAL TECHNIQUE The ISSYS LP Auxiliary Connector System includes connectors and an S-rod to allow the surgeon to lengthen an existing pedicle screw construct or stabilize a construct with implants that are not in alignment. The saddle pin design of the connectors accommodates various rod sizes allowing the system to be used on existing constructs. Standard ISSYS LP blockers are used to lock the construct. Connectors Short Offset Screw Connector [120015] Connector used when the screw does not line-up with the rod. The short offset connector is 20 mm in length and the rod end measures 6.35mm in diameter. Long Offset Screw Connector [120010] The 35mm long connector is used when the rod is further in distance from the screw. The rod end has a diameter of 6.35mm. Inline Rod to Rod Connector [120030] This connector is used to lengthen a rod construct which is in alignment. The rod to rod connector accommodates a variety of rod sizes from 5.5mm to 6.35mm and measures 35mm in length. Offset Rod to Rod Connector [120020] This offset rod to rod connector lengthens the pedicle screw construct without the need of removing the existing screws or bending the existing rod. The cut-out end attaches to the rod in the existing construct while the opposite side allows an S-rod to be inserted. S-Rod [120025] This rod was designed to lengthen an offset construct with the S shaped bend in the s-rod. Using the offset rod to rod connector, the s-rod can connect to the existing construct. The rod is 6.0mm in diameter and the straight shaft measures 200mm in length, which can easily be cut to desired length. Important: Do not use the auxiliary connectors on excessively bent rods. CUSTOM SPINE, INC. I 3

SURGICAL TECHNIQUE Offset Screw Connectors The Short [120015] or Long [120010] Offset Connector is placed under the existing rod at the point where the pedicle screw will be placed in an offset position, and the blocker is hand tightened on the connector using the blocker inserter. Once the screw is fully seated in the offset position, place the rod portion of the lateral offset connector into the head of the screw. The rod should extend past the screw head a minimum of 1mm. Using the blocker inserter, place a standard blocker on the screw and hand tighten. The construct is now ready for final tightening. Note: The Offset Connector is most easily applied in conjunction with the polyaxial screw. If used with a monoaxial screw, align the screw head perpendicular to the connector. Construct Extension A pedicle screw rod construct can be extended using the inline rod to rod connector [120030] or the offset rod to rod connector [120020]. Inline The inline rod to rod connector [120030] can be used to lengthen a construct when the newly inserted pedicle screws are in relative alignment. The connector accommodates multiple rod sizes and can be slipped onto the end of the rod on the existing construct. Hand tighten the blocker on the rod using the blocker inserter after making sure that the rod end is visible through the center hole on the connector. The new rod, selected from the standard ISSYS LP pedicle screw system, is placed into the head of the newly implanted screw and the end inserted into the opposite end of the inline rod to rod connector creating an end to end rod construct. Important: When using inline axial connectors, the rods must be clearly visible through the center hole. Failure to do so may lead to weaker interconnection between the rod and the blocker resulting in rod slippage. Using the blocker inserter, place a blocker on the connector and new screw and hand tighten all the blockers. Once all screws are hand tightened, the construct is ready for final tightening. 4 I ISSYS LP AUXILIARY CONNECTORS SURGICAL TECHNIQUE

SURGICAL TECHNIQUE Construct Extension, continued Offset The offset rod to rod connector [120020] can also be used to lengthen a construct when the newly inserted pedicle screws are in relative alignment and when overhang of the rod on the existing screw is less than 8 mm. Also, place the auxilary connector counter torque wrench between the two existing screws to ensure there is enough space to accommodate the wrench. If there is not enough space, the connector cannot be used. To create an offset rod to rod construct, place the open end of the offset rod to rod connector [120020] under the existing rod at the desired location and hand tighten the blocker using the blocker inserter. Once the blocker is inserted, measure for desired rod length and cut the S-rod [120025] accordingly on the straight end of the rod. Place the shaft of the rod into the head of the newly implanted pedicle screw and slip the rod into the closed circular hole of the connector. Ensure the rod sits 1mm past the connector. Using the blocker inserter, place one blocker into the closed threaded circular hole of the connector, and one blocker into the screw to final tighten the system. Once blockers have been inserted into the remaining pedicle screws and hand tightened, the construct is ready for final tightening. Important: The closed circular hole is only intended for use with the S-rod provided. Failure to do so may result in a weaker construct. Final Tightening Important: Final tighten all pedicle screws prior to tightening auxiliary connector blockers. The ISSYS LP torque wrench and auxiliary connector counter torque wrench [129000] are used for final tightening of the blockers. Insert the torque wrench inside the counter torque wrench shaft and align into the blocker. Align the Counter Torque Wrench handle in the direction of the connector. When assembled the torque/counter torque wrench has four groups of three arrows, two pointing up and one pointing down. At the starting position the downward pointing arrow is aligned with the arrow on the right. Apply leverage by pushing the two handles toward the middle until the downward pointing arrow is aligned with the bottom arrow on the left. Once the arrows are aligned, the prescribed tightening torque has been applied to the Blocker. Important: Exceeding the prescribed tightening torque by over levering the arrows past the final alignment can damage the implant and or instrument. Note: Over tightening the blocker could result in rod notching. CUSTOM SPINE, INC. I 5

IMPLANTS AND INSTRUMENTS SET ISSYS LP Connector System Tray [129100] The auxiliary connectors have been incorporated into the ISSYS LP Connector System Tray which included polyaxial cross connectors and monoaxial cross connectors. Level 1 Product Number Description Quantity 062145 6.0mm Polyaxial Cross Connector, Small 6 062165 6.0mm Polyaxial Cross Connector, Medium 4 062185 6.0mm Polyaxial Cross Connector, Large 2 062217 17mm Monoblock Cross Connector 2 062218 18mm Monoblock Cross Connector 2 062219 19mm Monoblock Cross Connector 2 062220 20mm Monoblock Cross Connector 2 062223 23mm Monoblock Cross Connector 2 062226 26mm Monoblock Cross Connector 2 062345 6.35mm Polyaxial Cross Connector, Small 2 062365 6.35mm Polyaxial Cross Connector, Medium 2 062385 6.35mm Polyaxial Cross Connector, Large 2 069000 Caliper 1 069003 Bar Holder 1 069006 3mm Tightener 1 120010 Long Offset Connector 4 120015 Short Offset Connector 4 120030 Inline Rod to Rod Connector 4 120025 S-rod 3 120020 Offset Rod to Rod Connector 4 Level 2 Product Number Description Quantity 069001 Bar Cutter 1 069002 Bar Bender 1 069004 Connector Inserter 1 129000 Auxiliary Connector s Counter Torque Wrench 1 6 I ISSYS LP AUXILIARY CONNECTORS SURGICAL TECHNIQUE

CUSTOM SPINE CUSTOM SPINE ISSYS LP Spinal Fixation System ISSYS LP Polyaxial Pedicle Screw System - ISSYS LP Monoaxial Screw System CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a licensed physician. NON STERILE PRODUCT MUST BE STERILIZAED PRIOR TO USE SINGLE USE ONLY THE ISSYS LP SPINAL FIXATION SYSTEM HAS NOT BEEN EVALUATED FOR SAFETY AND COMPATABILITY IN THE MR ENVIRONMENT. THE ISSYS LP SPINAL FIXATION SYSTEM HAS NOT BEEN TESTED FOR HEATING OR MIGRATION IN THE MR ENVIRONMENT. ISSYS LP AUXILLARY CONNECTORS ARE USED FOR PEDICULAR FIXATION IN THE IMMOBILIZATION AND STABILIZATION OF THE POSTERIOR NON CERVICAL (T1-S1) SPINE. The Custom Spine ISSYS LP Spinal Fixation Systems are comprised of spinal implants for fixation of the non cervical spine. They include rods, screws (Monoaxial and Polyaxial), blockers, staples, and transverse connectors. The components are manufactured from Titanium alloy. The screws are available in various sizes from 4.5mm to 10mm diameters with lengths ranging from 25mm to 100mm. MATERIALS Titanium alloy: Ti6Al4V 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 ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: For pedicular use: When used as 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). 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. The ISSYS LP Spinal Fixation System is also intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either sever spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. When used as non pedicular fixation system: The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following: Degenerative disc disease 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. 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 affect 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 is 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. in the use of the implant, leading to failure or other complications. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation. Other medical or surgical condition 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. ISSYS LP Auxiliary Connectors The ISSYS LP auxiliary connectors were designed to provide medial-lateral variability for the ISSYS LP system and for revision applications. The ISSYS LP auxiliary connector system includes offset connectors and rods, as well as end to end connectors. Warning: Ensure the connectors are not placed at a severely bent portion of the rod. Warning : The S-Rod is a 6.0 mm diameters rod to be used only in conjunction with the offset rod to rod connector. CUSTOM SPINE, INC. I 7

Custom Spine, Inc. 1140 Parsippany Boulevard Suite #201 Parsippany, NJ 07054 Phone (973) 808-0019 Fax (973) 808-0707 www.customspine.com Product Number MECO 001010 Rev. B