Spine and Low Back Systems Instructions for Use

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constructs formed from the Original System to rod constructs from the Secondary System per the table below.

en CAUTION: USA law restricts this device to sale by or on the order of physician.

IMPORTANT NOTE TO OPERATING SURGEON ISOLA, VSP, MOSS MIAMI, EXPEDIUM, VIPER, TIMX and MONARCH spinal implants, like any other temporary internal fixation devices, have a finite useful life. The patient’s activity level has a significant impact on this useful life. Your patient must be informed that any activity increases the risk of loosening, bending, or breaking of the implant components. It is essential to instruct patients about restrictions to their activities in the postoperative period and to examine patients postopera­tively to evaluate the development of the fusion mass and the status of the implant components. Even if solid bone fusion occurs, implant components may nevertheless bend, break, or loosen. Therefore, the patient must be made aware that implant components may bend, break, or loosen even though restrictions in activity are followed. Because of the limitations imposed by anatomic considerations and modern surgical materials, metallic implants cannot be made to last indefinitely. Their purpose is to provide temporary internal support while the fusion mass is consolidating. These types of implants are more likely to fail if no bone graft is used, if a pseudarthrosis develops, or if patients have severe or multiple preoperative curves. The surgeon may remove these implants after bone fusion occurs. The possibility of a second surgical procedure must be discussed with the patient, and the risks associated with a second surgical procedure must also be discussed. If the implants do break, the decision to remove them must be made by the physician who must consider the condition of the patient and the risks associated with the presence of the broken implant.

DESCRIPTION DePuy Spine implants are NOT compatible with implants from other manufacturers unless otherwise specified. Implants from each of the DePuy Spine systems are NOT interchangeable with implants from other DePuy Spine systems unless otherwise specified.

ORIGINAL SYSTEM EXPEDIUM/ VIPER

SECONDARY SYSTEM(S)

EXPEDIUM/VIPER, Connects To ISOLA/TIMX, MONARCH, MOSS MIAMI

EXPEDIUM Titanium

Connects To

MOUNTAINEER

EXPEDIUM 5.5 Titanium

Connects To

Synthes SYNAPSE

ISOLA/TIMX, ISOLA/TIMX Connects To EXPEDIUM/VIPER, MONARCH MONARCH, MONARCH Connects To EXPEDIUM/VIPER, ISOLA/TIMX MOSS MIAMI, MOSS MIAMI Connects To EXPEDIUM/VIPER, ISOLA/TIMX Dual diameter rods used to connect EXPEDIUM to the Synthes SYNAPSE System are limited to the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods from the SYNAPSE System. Implants made of different materials are NOT compatible unless otherwise specified. The table below specifies implant material compatibility. MATERIAL

COMPATIBLE WITH

Stainless Steel alloys

Stainless Steel alloys

Titanium alloys Titanium alloys, Cobalt-ChromiumMolybdenum, Cobalt-NickelChromium-Molybdenum, PEEK, Commercially Pure Titanium PEEK

Titanium alloys

Cobalt-ChromiumTitanium alloys, Cobalt-NickelMolybdenum Chromium-Molybdenum Cobalt-NickelChromium-Molybdenum

Titanium alloys, Cobalt-Chromium-Molybdenum

Commercially Pure Titanium

Titanium alloys

Implants designed to interface with a specific rod diameter are NOT compatible with other rod diameters unless otherwise specified. Implants designed to interface with a specific rod diameter are compatible with rods from other systems having the same diameter and same material per the table below.

DePuy Spine prepares Surgical Technique Manuals showing the use of the implants and instruments for each Spine System. Contact your DePuy Spine sales representative to obtain copies of these Surgical Technique Manuals.

Dual diameter rod components can have a combination of rod diameters corresponding to the existing straight rod diameters from each of the Spine Systems listed in the table below. These dual diameter rods can be used to connect rod

ISOLA SPINE SYSTEM The Posterior ISOLA Spine System is a rod-based system consisting of spinal rods, eye-rods, plate-rod combinations (PRC), dual rod connectors, tandem connectors, ISOLA

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Modular Cross Connector (MCC) transverse connectors, EZ-X transverse connectors, other transverse connectors, solid spinal hooks, open back spinal hooks, sublaminar wires, pedicle screws, open and closed pedicle screws, cable/wire pedicle screws used with wire or Songer® Cable, iliac screws, and sacral screws. The cable/wire pedicle screw is intended to be used with stainless steel ISOLA Beaded Sublaminar Wire, manufactured by DePuy Spine, Inc., or with the stainless steel Single Cable with Crimp and Bar and the Single ISOLA Cable with Eyelet Leader components of the Songer Spinal Cable System, manufactured by Pioneer Surgical Technologies and distributed by DePuy Spine, Inc. The ISOLA Polyaxial Washers are NOT for use with ISOLA Band Clamp or ISOLA Twister Connector. The ISOLA Spine System is compatible with other systems as follows: • The TIMX Low Back System pedicle and sacral screws, washers, slotted connectors, and twister connectors are used in conjunction with the ISOLA Spine System titanium components to comprise a rod-based spinal fixation system. • CrossOver transverse connectors • EXPEDIUM SFX® Cross Connector System • EXPEDIUM Spine System dual rod and lateral connectors, and sacral extenders • Constructs incorporating inter-system single or dual diameter rods as defined above EXPEDIUM 4.0mm diameter screws are not for use with dual diameter rods when connecting to DePuy Spine Systems. The Pediatric ISOLA Spine System consists of a pediatric plate-rod combination (PRC) and side-tightening hooks with downsized dimensions to accommodate the anatomic limitations found where internal fixation is performed on pediatric or small stature individuals. The PRC and hooks are used with components already available in the ISOLA Spine System including 3/16 inch diameter rods, transverse connectors, sublaminar wires and cables, dual and tandem connectors, slotted connectors, and sacral and iliac screws. The Anterior ISOLA Spine System consists of spinal rods, open and closed screws, washers, caps, set screws, washers and staples. The Anterior ISOLA staples, washers, and screws are intended to be attached to the lateral aspect of the vertebral bodies from T5 to L4, and SHOULD NOT be attached to the anterior aspect. (See Precautions section.) Refer to the Anterior ISOLA Technique Manual for important implant assembly instructions. The Posterior, Pediatric, and Anterior ISOLA Spine System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications or ASTM F-1314 specifications.

VSP SPINE SYSTEM The VSP Spine System consists of pedicle screws, spine plates, transverse connectors, washers, and nuts. The VSP Spine System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications or ASTM F-1314 specifications.

MOSS MIAMI SPINE SYSTEM The MOSS MIAMI Spine System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, hooks, reduction hooks, MOSS MIAMI transverse connectors, other transverse connectors, axial connectors, staple washers, and sacral extenders. The MOSS MIAMI Spine System is compatible with other systems as follows: • ISOLA EZ-X transverse connectors • CrossOver transverse connectors • EXPEDIUM SFX Cross Connector System • EXPEDIUM Spine System dual rod and lateral connectors, and sacral extenders • Constructs incorporating inter-system single or dual diameter rods as defined above The CrossOver transverse connector is NOT for use with the MOSS MIAMI 4.0mm Rod System. The MOSS MIAMI Spine System components are available in titanium alloy conforming to ASTM F-136 specifications as well as stainless steel conforming to ASTM F-138 specifications. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively. EXPEDIUM 4.0mm diameter screws are not for use with dual diameter rods when connecting to DePuy Spine Systems.

EXPEDIUM SPINE SYSTEM The EXPEDIUM Spine System consists of longitudinal rods, monoaxial screws, polyaxial screws, uni-planar screws, reduction screws, cable/wire screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers. The EXPEDIUM Spine System is compatible with other systems through the use of single or dual rod connectors, lateral connectors, sacral extenders and dual diameter rods as follows: • ISOLA Spine System rods • VIPER System rods • MONARCH Spine System rods • MOSS MIAMI Spine System rods • TIMX Low Back System rods • Synthes SYNAPSE System rods

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The cable/wire screw is intended to be used with stainless steel ISOLA Beaded Sublaminar Wire, manufactured by DePuy Spine, Inc., or with the stainless steel Single Cable with Crimp and Bar and the Single ISOLA Cable with Eyelet Leader components of the Songer Spinal Cable System, manufactured by Pioneer Surgical Technologies and distributed by DePuy Spine, Inc. The EXPEDIUM Spine System components are available in commercially pure titanium or titanium alloy conforming to ASTM F-67 or ASTM F-136 specifications, stainless steel conforming to ASTM F-138, ASTM F-1314, or F-2229 ­specifications, cobalt-nickel-chromium-molybdenum alloy wire conforming to ASTM F-562 specifications, as well as ­longitudinal rods in cobalt-chromium-molybdenum alloy conforming to ASTM F-1537 and PEEK polymer specifications. Cobalt-chromium-molybdenum alloy rods and cobalt-nickelchromium-molybdenum alloy wires are intended for use with titanium components only. Cobalt-chromium-molybdenum rods of 4.5mm diameter should only be used with 4.35mm thread diameter and larger titanium screws. PEEK longitudinal rods are only intended for use with titanium-alloy screws that utilize the titanium-alloy Single Innie (SI) set screw specifically designed for use with PEEK rods. PEEK rods are not intended for use with cross connectors or EXPEDIUM 5.5 polyaxial screws 8mm to 12mm in diameter. Ring nut and set screw assemblies are only intended for use with polyaxial, uni-planar, and monoaxial single innie (SI) pedicle screws and pedicle hooks within the EXPEDIUM 4.5mm and 5.5mm stainless steel and titanium Systems. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively. EXPEDIUM 4.0mm diameter screws are not for use with dual diameter rods when connecting to DePuy Spine Systems.

VIPER SYSTEM VIPER, VIPER® 2 and VIPER PRIME™ are all part of the VIPER System. For simplicity in these instructions for use, only the encompassing VIPER name is used. The VIPER System consists of cannulated polyaxial screws, monoaxial screws, uni-planar screws, reduction screws, and rods used in a percutaneous approach. The VIPER System is compatible with other systems as follows: • EXPEDIUM SFX Cross Connector System • EXPEDIUM Spine System dual rod and lateral connectors, and sacral extenders • Constructs incorporating inter-system single or dual diameter rods as defined above The VIPER System components are available in titanium alloy conforming to ASTM F-136 specifications, stainless steel conforming to ASTM F-138 or ASTM F-1314 specifications, as well as longitudinal rods in cobalt-chromium-molybdenum alloy conforming to ASTM F-1537, and PEEK polymer.

Cobalt-chromium-molybdenum alloy rods are intended for use with titanium components only. PEEK longitudinal rods are only intended for use with titaniumalloy screws that utilize the titanium-alloy Single Innie (SI) set screw specifically designed for use with PEEK rods. PEEK rods are not intended for use with VIPER PRIME polyaxial screws. PEEK rods are not intended for use with cross connectors or VIPER/VIPER2 polyaxial screws 8mm to 12mm in diameter. The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively. EXPEDIUM 4.0mm diameter screws are not for use with dual diameter rods when connecting to DePuy Spine Systems.

TIMX LOW BACK SYSTEM The TIMX Low Back System is both a plate-based and a rodbased system. The plate-based system consists of pedicle screws, spine plates, transverse connectors, J-hooks, washers, nuts, and set screws. The rod-based system consists of spinal rods, pedicle screws, set screws, various slotted connectors, and transverse connectors. The TIMX Spine System is compatible with other systems as follows: • ISOLA Modular Cross Connector (MCC) transverse connectors • ISOLA EZ-X transverse connectors • CrossOver transverse connectors • EXPEDIUM SFX Cross Connector System • EXPEDIUM Spine System dual rod and lateral connectors, and sacral extenders • Constructs incorporating inter-system single or dual diameter rods as defined above The TIMX Low Back System components are available in titanium alloy conforming to ASTM F-136 specifications. EXPEDIUM 4.0mm diameter screws are not for use with dual diameter rods when connecting to DePuy Spine Systems.

MONARCH SPINE SYSTEM The MONARCH Spine System is both a plate-based and a rod-based system. The plate-based system consists of pedicle screws, spine plates, transverse connectors, J-hooks, washers, nuts, and set screws. The rod-based system consists of spinal rods, pedicle screws, polyaxial screws, caps, set screws, various slotted connectors, open and closed hooks, various rod-to-rod connectors, and transverse connectors. The MONARCH nested slotted plate nut and washers are intended to be used only with the MONARCH nested slotted plate and is NOT for use with other MONARCH plates. The MONARCH Spine System is compatible with other systems as follows: • ISOLA Modular Cross Connector (MCC) transverse connectors • ISOLA EZ-X transverse connectors

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• CrossOver transverse connectors • EXPEDIUM SFX Cross Connector System • EXPEDIUM Spine System dual rod and lateral connectors, and sacral extenders • Constructs incorporating inter-system single or dual diameter rods as defined above The MONARCH Spine System components are available in commercially pure titanium or titanium alloy conforming to ASTM F-67 and ASTM F-136 specifications. EXPEDIUM 4.0mm diameter screws are not for use with dual diameter rods when connecting to DePuy Spine Systems.

INDICATIONS The ISOLA, VSP, MOSS MIAMI, TIMX and MONARCH Spine Systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The EXPEDIUM and VIPER Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM and VIPER Spine Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The ISOLA, VSP, MOSS MIAMI, TIMX and MONARCH Spine Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 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.

CLEANING AND STERILIZATION

The ISOLA, MOSS MIAMI, TIMX and MONARCH Spine Systems are also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

For the implants supplied sterile, the contents are sterile unless the package is damaged, opened, or the expiration date on the device label has passed. The integrity of the packaging should be checked to ensure that the sterility of the contents is not compromised. Remove implants from packaging, using aseptic technique, only after the correct size has been determined.

The ISOLA, VSP, and MONARCH Spine Systems when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine. The ISOLA and MOSS MIAMI Spine Systems when used as anterior thoracic/lumbar screw fixation systems, are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). The MONARCH Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4.75mm, 5.5mm, and 6.35mm diameter rod systems.

Implants and instruments of the ISOLA, VSP, MOSS MIAMI, EXPEDIUM, VIPER, TIMX and MONARCH Spine Systems may be provided either sterile or non-sterile and this will be clearly identified on the product labels.

Sterile Implants

PRECAUTION: Do not use implants if the condition of the package and/or labeling indicates a chance that the devices may not be sterile. Implants supplied sterilized from the manufacturer must not be resterilized.

Non-sterile Implants For the implants supplied non-sterile, they will be supplied clean. ISO 8828 or AORN recommended practices for in-hospital sterilization should be followed for all components.

Cleaning instructions Inspect visually for damage or the presence of blood or ­tissue. If blood or tissue is observed on the implant, it must be thoroughly cleaned manually using a soft brush and neutral pH detergent or discarded. • Enzyme soak • Rinse

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• Ultrasonic cleaning (10-20 minutes) • Rinse • Automated cleaning in a washer disinfector with lid on to contain implant components • Dry Avoid impact, scratching, bending or surface contact with any materials that might affect the implant surface or configuration. Special attention shall be paid to recesses since both chemicals and rinse water may be entrapped in them.

mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. CoCr tapered rods are not intended to connect the EXPEDIUM Spine System to the Synthes SYNAPSE System. PRECAUTION: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.

RECOMMENDATIONS FOR STEAM STERILIZATION Wrap implants in accordance with local procedures using standard wrapping techniques such as those described in ANSI/AAMI ST79:2006.

The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but must also be aware of the mechanical and metallurgical limitations of metallic surgical implants. Postoperative care is extremely important. The patient must be instructed in the limitations of the metallic implant and be warned regarding weight bearing and body stresses on the appliance prior to firm bone healing. The patient should be warned that noncompliance with postoperative instructions could lead to failure of the implant and possible need thereafter for additional surgery to remove the device.

In a properly functioning calibrated steam sterilizer, independent testing has shown that effective sterilization may be achieved using the following parameters: For the ISOLA, VSP, MOSS MIAMI, TIMX, and MONARCH Spine Systems: Cycle: Pre-Vacuum Temperature: 270°F (132°C) Exposure time: 6 minutes

Refer to the individual system surgical technique manuals for additional important information.

For the EXPEDIUM and VIPER Spine Systems: Cycle: Pre-Vacuum Temperature: 270°F (132°C) Exposure time: 4 minutes Drying Time: 60 minutes

DePuy Spine Spinal System components should not be used with components from other manufacturers unless otherwise specified.

Post-sterilization drying of the sterilization load within the sterilization vessel is standard practice in hospitals. ANSI/AAMI ST79:2006, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities” provides guidance to hospitals for selecting appropriate drying parameters based on the sterilization cycle that is being conducted. Sterilizer manufacturers also typically provide recommendations for drying parameters for their specific equipment.

Stainless steel components may interfere with the quality of imaging obtained using MRI. When using spine plates, use the shortest plate possible for each procedure. Minimal plate length will reduce the possibility of interference with other bony structures. When using spine plates, it is important that the plates be contoured to mirror or to create the desired anatomic curves.

Implants previously implanted must not be re-used.

During the surgical procedure, the rods may be cut to size and shaped to provide correction and maintain proper anatomic lordotic and kyphotic alignment.

MAGNETIC RESONANCE (MR) COMPATIBILITY

When using anterior thoracic/lumbar screw fixation systems, staples, staple washers and washers are available to optimize proper staple/screw/rod alignment and stability.

The ISOLA, VSP, MOSS MIAMI, EXPEDIUM, VIPER, TIMX, and MONARCH Spine Systems have not been evaluated for safety and compatibility in the MR environment. They have not been tested for heating or migration in the MR environment.

Screw diameters of 11mm and 12mm are indicated for use only in the sacrum or Ilium. Pre-operative use of CT imaging to determine the appropriate screw diameter, length, insertion trajectory, and clearance is strongly recommended when large diameter screws are indicated.

USAGE WARNING: 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

EXPEDIUM 4.0mm diameter screws are not for use with dual diameter rods when connecting to DePuy Spine Systems. PEEK longitudinal rods are only intended for use with titanium-alloy screws that utilize the titanium-alloy Single

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Innie (SI) set screw specifically designed for use with PEEK rods. PEEK rods are not intended for use with VIPER PRIME polyaxial screws. PEEK rods are not intended for use with cross connectors or VIPER/VIPER2 polyaxial screws 8mm to 12mm in diameter. PEEK rods are not intended for use with cross connectors or EXPEDIUM 5.5 polyaxial screws 8mm to 12mm in diameter. After solid fusion occurs, these devices serve no functional purpose and may be removed. In some cases, removal is indicated because the implants are not intended to transfer or to support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient taking into consideration the patient’s general medical condition and the potential risk to the patient of a second surgical procedure. Based on fatigue testing results, when using the MOSS MIAMI 4.0mm Rod System components in a unilateral anterior construct, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system. These devices are not intended or expected to be the only mechanism for support of the spine. Regardless of the etiology of the spinal pathology, for which implantation of these devices was chosen, it is the expectation and requirement that a spinal fusion or arthrodesis be planned and obtained. Without solid biological support provided by spinal fusion, the devices cannot be expected to support the spine indefinitely and will fail in any of several modes. These modes may include bonemetal interface failure, implant fracture, or bone failure. When using Pediatric ISOLA posterior spinal instrumentation in children, it is preferable that children be above the age of 10 but need not have reached skeletal maturity. In special circumstances, implants may be used at younger ages. Due to the difficulties in conducting randomized prospective studies with children, there is limited clinical data on pediatric use of these spinal systems. The implanting surgeon should consider carefully the size and type of implants most suitable for the pediatric patient’s age, size, weight and skeletal maturity. Since pediatric patients may have additional growth potential following implant surgery, the likelihood of a subsequent removal and/or revision surgery is greater in these patients.

POSTOPERATIVE MOBILIZATION Until X-rays confirm the maturation of the fusion mass, external immobilization (such as bracing or casting) is recommended. Instructions to the patient to reduce stress on the implants are an equally important part of the attempt to avoid the occurrence of clinical problems that may accompany fixation failure.

CONTRAINDICATIONS The PEEK rods of EXPEDIUM Spine System and VIPER System are contraindicated for degenerative disc disease.

Disease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation. Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system. Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure. See also the WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES section of this insert.

WARNINGS, PRECAUTIONS, AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES Following are specific warnings, precautions, and possible adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery.

WARNINGS 1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape, and design of the implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing. 2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load-sharing devices which are used to obtain alignment until normal healing occurs. If healing is delayed, or does not occur, the implant may eventually break due to metal fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other

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conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure.

PRECAUTIONS

3. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerate the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion often accelerates fatigue fracture of implants. The amount of metal compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, etc., which come into contact with other metal objects, must be made from like or compatible metals. 4. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be of extreme importance to the eventual success of the procedure: A. The patient’s weight. An overweight or obese patient can produce loads on the device that can lead to failure of the appliance and the operation. B. The patient’s occupation or activity. If the patient is involved in an occupation or activity that includes heavy lifting, muscle strain, twisting, repetitive bending, stooping, running, substantial walking, or manual labor, he/she should not return to these activities until the bone is fully healed. Even with full healing, the patient may not be able to return to these activities successfully. C. A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications. D. Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary remedy. E. Foreign body sensitivity. The surgeon is advised that no preoperative test can completely exclude the possibility of sensitivity or allergic reaction. Patients can develop sensitivity or allergy after implants have been in the body for a period of time. F. Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where bone graft is used. Additionally, smoking has been shown to cause diffuse degeneration of intervertebral discs. Progressive degeneration of adjacent segments caused by smoking can lead to late clinical failure (recurring pain) even after successful fusion and initial clinical improvement.

1. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted metal implant should never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage. Reuse can compromise device performance and patient safety. Reuse of single use devices can also cause cross-contamination leading to patient infection. 2. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of metal implants should only be done with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Bending of screws will significantly decrease the fatigue life and may cause failure. 3. CONSIDERATIONS FOR REMOVAL OF THE IMPLANT AFTER HEALING. If the device is not removed after the completion of its intended use, any of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending, loosening, and/or breakage, which could make removal impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6) Possible increased risk of infection; and (7) Bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risks involved with a second surgery. 4. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient’s ability and willingness to follow instructions are among the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant, and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sports participation. The patient should understand that a metallic implant is not as strong as normal healthy bone and could loosen, bend and/or break if excessive demands are placed on it, especially in the absence of complete bone healing. Implants displaced or damaged by improper activities may migrate and damage the nerves or blood vessels. An active, debilitated, or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation. 5. CORRECT PLACEMENT OF ANTERIOR SPINAL IMPLANT. Due to the proximity of vascular and neurologic structures to the implantation site, there are risks of serious or fatal hemorrhage and risks of neurologic damage with the use of this product. Serious or fatal hemorrhage may occur if the great vessels are eroded or punctured during implantation or are subsequently damaged due to breakage of implants,

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migration of implants or if pulsatile erosion of the vessels occurs because of close apposition of the implants.

POSSIBLE ADVERSE EFFECTS Potential complications and adverse effects with these systems are similar to those with other spinal instrumentation systems. These complications may include: 1. Bending or fracture of implant. 2. Loosening of the implant. 3. Metal sensitivity or allergic reaction to a foreign body. 4. Infection, early or late. 5. Nonunion, delayed union. 6. Decrease in bone density due to stress shielding. 7. Pain, discomfort, or abnormal sensations due to the presence of the device. 8. Nerve damage due to surgical trauma or presence of the device. Neurological difficulties including bowel and/or bladder dysfunction, impotence, retrograde ejaculation, and paraesthesia. 9. Bursitis. 10. Paralysis. 11. Dural tears experienced during surgery could result in the need for further surgery for dural repair, a chronic CSF leak or fistula, and possible meningitis. 12. Death. 13. Vascular damage due to surgical trauma or presence of the device. Vascular damage could result in catastrophic or fatal bleeding. Malpositioned implants adjacent to large arteries or veins could erode these vessels and cause catastrophic bleeding in the late postoperative period.

14. Screw back out, possibly leading to implant loosening, and/or reoperation for device removal. 15. Damage to lymphatic vessels and/or lymphatic fluid exudation. 16. Spinal cord impingement or damage. 17. Fracture of bony structures. 18. Degenerative changes or instability in segments adjacent to fused vertebral levels.

Additional Possible Adverse Effects for Anterior ISOLA Spine System 19. Loss of normal spinal contours. 20. Cessation of growth of the fused portion of the spine. 21. Pulmonary complications.

LIMITED WARRANTY AND DISCLAIMER PRODUCTS FROM DEPUY SYNTHES PRODUCTS, INC. ARE SOLD WITH A LIMITED WARRANTY TO THE ORIGINAL PURCHASER AGAINST DEFECTS IN WORKMANSHIP AND MATERIALS. ANY OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANT­ ABILITY OR FITNESS, ARE HEREBY DISCLAIMED. IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN THE DATE OF ISSUE/REVISION OF THIS INSERT AND THE DATE OF CONSULTATION, CONTACT DEPUY SYNTHES SPINE FOR CURRENT INFORMATION AT +1-800-365-6633 OR AT +1-508-880-8100.

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SYMBOL TRANSLATION LOT LOT NUMBER REF REF CATALOG NUMBER

STERILE STERILE SINGLE USE

DO NOT RESTERILIZE

QTY QUANTITY SZ SIZE MADE IN MADE IN NTI NEURAL TISSUE INSTRUMENT IOM NEUROMONITORING INSTRUMENTS

Federal (USA) law restricts this device to sale by or on the order of a physician

T2

ATTENTION. SEE INSTRUCTIONS FOR USE

T1

Lower Limit of temperature = T1 Upper Limit of temperature = T2

PACKAGE CONTAINS FLAMMABLE LIQUID

25°C

STERILE A Sterile medical device processed using aseptic technique STERILE R STERILIZATION BY IRRADIATION STERILE EO STERILIZATION BY ETHYLENE OXIDE LATEX FREE LATEX FREE

STORE AT ROOM TEMPERATURE

KEEP AWAY FROM SUNLIGHT

DO NOT USE IF PACKAGE IS DAMAGED

NON STERILE

MSR MEASURING DEVICE

NONSTERILE NONSTERILE

MANUFACTURER

DATE OF MANUFACTURE US REP US REPRESENTATIVE EC REP AUTHORIZED EUROPEAN REPRESENTATIVE DIST DISTRIBUTED BY XXXX-XX USE BY

MATERIAL MATL A/T ACROFLEX®/Ti ACROFLEX®/Titanium

P/F PL/FOAM Plastic/Foam

A AI Aluminum

PY Polyester

A/P Al/PL Aluminum/Plastic

PEEK/C PEEK/CARBON FIBER COMPOSITE Polyether Ether Ketone/ Carbon Fiber Composite

B/R Ba/RADEL® Barium/RADEL® Ba/PEEK Barium Sulfate (BaSO4)/ PEEK Polymer CaP CALCIUM PHOSPHATE Calcium Phosphate CM CoCrMo Cobalt Chromium Molybdenum CMTC CoCrMo/Ti/CALCIUM PHOSPHATE Cobalt Chromium Molybdenum/Titanium/ Calcium Phosphate CoNiCrMo

PEEK OPTIMA® Polyether Ether Ketone P

POLYMER Polymer

P/CM PE/CoCrMo Polyethylene/Cobalt Chromium Molybdenum P/C POLYMER/CARBON FIBER COMPOSITE Polymer/ Carbon Fiber Composite

SRSI SS/RADEL®/SILICONE Stainless Steel/RADEL® / Silicone SRSN SS/RADEL®/ SILICONE/Ti Al Nitride Stainless Steel/RADEL® / Silicone/Titanium Aluminum Nitride SS/RADEL®/ SILICONE/Ti Nitride Stainless Steel/RADEL®/ Silicone/Titanium Nitride SRTA SS/RADEL®/Ti Al Nitride Stainless Steel/RADEL® / Titanium Aluminum Nitride STA SS/Ti Al Nitride Stainless Steel/ Titanium Aluminum Nitride S/U SS/ULTEM Stainless Steel/Ultem

Si/NITINOL Silicone/Nitinol 11 of 164 T Ti Titanium and its alloys S SS

Ti/HA Titanium/Hydroxyapatite Ti/UHMWPE/HA Titanium/Ultra-High Molecular Weight Polyethylene/Hydroxyapatite SS/Ti Stainless Steel/Titanium SS/Al/SILICONE Stainless Steel/ Aluminum/Silicone SS/SILICA GLASS Stainless Steel/Silica Glass SS/SILICA GLASS/ PL/SILICONE Stainless Steel/Silica Glass/ Plastic /Silicone SS/SILICA GLASS/ RADEL® /SILICONE Stainless Steel/Silica Glass/ RADEL® /Silicone SS/SILICA GLASS/

restricts this device to sale by or on the order of a physician

NONSTERILE NONSTERILE

MSR MEASURING DEVICE

KEEP AWAY FROM SUNLIGHT

XXXX-XX USE BY

MATERIAL MATL A/T ACROFLEX®/Ti ACROFLEX®/Titanium

P/F PL/FOAM Plastic/Foam

A AI Aluminum

PY Polyester

A/P Al/PL Aluminum/Plastic

PEEK/C PEEK/CARBON FIBER COMPOSITE Polyether Ether Ketone/ Carbon Fiber Composite

B/R Ba/RADEL® Barium/RADEL® Ba/PEEK Barium Sulfate (BaSO4)/ PEEK Polymer CaP CALCIUM PHOSPHATE Calcium Phosphate CM CoCrMo Cobalt Chromium Molybdenum CMTC CoCrMo/Ti/CALCIUM PHOSPHATE Cobalt Chromium Molybdenum/Titanium/ Calcium Phosphate CoNiCrMo Cobalt Nickel Chromium Molybdenum F

FOAM Foam

SRSI SS/RADEL®/SILICONE Stainless Steel/RADEL® / Silicone

PEEK OPTIMA® Polyether Ether Ketone P

POLYMER Polymer

P/CM PE/CoCrMo Polyethylene/Cobalt Chromium Molybdenum P/C POLYMER/CARBON FIBER COMPOSITE Polymer/ Carbon Fiber Composite Si/NITINOL Silicone/Nitinol

SRSN SS/RADEL®/ SILICONE/Ti Al Nitride Stainless Steel/RADEL® / Silicone/Titanium Aluminum Nitride SS/RADEL®/ SILICONE/Ti Nitride Stainless Steel/RADEL®/ Silicone/Titanium Nitride SRTA SS/RADEL®/Ti Al Nitride Stainless Steel/RADEL® / Titanium Aluminum Nitride STA SS/Ti Al Nitride Stainless Steel/ Titanium Aluminum Nitride S/U SS/ULTEM Stainless Steel/Ultem T Ti Titanium and its alloys

S SS Stainless Steel S/A SS/Al Stainless Steel/Aluminum

HA Hydroxyapatite

SBR SS/Ba/RADEL® Stainless Steel/Barium/ RADEL®

NiTi Ni/Ti Nickel/Titanium

S/P SS/PHENOLIC Stainless Steel/Phenolic

PL Plastic

S/PL SS/PL Stainless Steel/Plastic

S/R SS/RADEL® Stainless Steel/RADEL® R/T POLYOLEFIN RUBBER/Ti Polyolefin Rubber/Titanium T/A Ti/Al Titanium/Aluminum Ti/CoCrMo Titanium/Cobalt Chromium Molybdenum

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Ti/HA Titanium/Hydroxyapatite Ti/UHMWPE/HA Titanium/Ultra-High Molecular Weight Polyethylene/Hydroxyapatite SS/Ti Stainless Steel/Titanium SS/Al/SILICONE Stainless Steel/ Aluminum/Silicone SS/SILICA GLASS Stainless Steel/Silica Glass SS/SILICA GLASS/ PL/SILICONE Stainless Steel/Silica Glass/ Plastic /Silicone SS/SILICA GLASS/ RADEL® /SILICONE Stainless Steel/Silica Glass/ RADEL® /Silicone SS/SILICA GLASS/ SILICONE Stainless Steel/ Silica Glass/Silicone S/SI SS/SILICONE Stainless Steel/Silicone SS/WC/SILICONE Stainless Steel/Tungsten Carbide/Silicone W/C Tungsten Carbide

Ù˘ Û˘Û΢‹˜ ·˘Ù‹˜ Û ȷÙÚfi ‹ ηÙfiÈÓ ÂÓÙÔÏ‹˜ È·ÙÚÔ‡

ΚΡΑΤΗΣΤΕ ΜΑΚΡΙΑ ΑΠΟ ΤΟ ΗΛΙΑΚΟ ΦΩΣ

MSR ΣΥΣΚΕΥΗ ΜΕΤΡΗΣΗΣ

NONSTERILE ΜΗ ΣΤΕΙΡΟ

XXXX-XX ∏ª∂ƒ√ª∏¡π∞ §∏•∏™

ΥΛΙΚΟ MATL A/T ACROFLEX®/Ti ACROFLEX® / ∆ÈÙ¿ÓÈÔ

PY ¶ÔÏ˘ÂÛÙ¤Ú·˜

A AI ∞ÏÔ˘Ì›ÓÈÔ

PEEK/C PEEK/CARBON FIBER COMPOSITE Πολυαιθεροαιθεροκετόνη/ Σύνθετο ινών άνθρακα

A/P Al/PL ∞ÏÔ˘Ì›ÓÈÔ / ¶Ï·ÛÙÈÎfi B/R Ba/RADEL® µ¿ÚÈÔ / RADEL® Ba/PEEK Θειικό βάριο (BaSO4) / Πολυμερέσ πολυαιθεροαιθεροκετόνησ (PEEK) CaP CALCIUM PHOSPHATE ºˆÛÊÔÚÈÎfi ·Û‚¤ÛÙÈÔ CM CoCrMo Κοβάλτιο χρώμιο μολυβδαίνιο CMTC CoCrMo/Ti/CALCIUM PHOSPHATE ∫Ô‚¿ÏÙÈÔ ÃÚÒÌÈÔ ªÔÏ˘‚‰·›ÓÈÔ/ ∆ÈÙ¿ÓÈÔ / ºˆÛÊÔÚÈÎfi ·Û‚¤ÛÙÈÔ CoNiCrMo Κοβάλτιο Νικέλιο Χρώμιο Μολυβδαίνιο F FOAM ∞ÊÚ҉˜ ˘ÏÈÎfi HA À‰ÚÔ͢··Ù›Ù˘ NiTi Ni/Ti ¡ÈΤÏÈÔ / ∆ÈÙ¿ÓÈÔ PL ¶Ï·ÛÙÈÎfi P/F PL/FOAM ¶Ï·ÛÙÈÎfi / ∞ÊÚ҉˜ ˘ÏÈÎfi

PEEK OPTIMA® Πολυαιθερική αιθερική κετόνη P

POLYMER ¶ÔÏ˘ÌÂÚ¤˜

P/CM PE/CoCrMo ¶ÔÏ˘·Èı˘Ï¤ÓÈÔ / ∫Ô‚¿ÏÙÈÔ ÃÚÒÌÈÔ ªÔÏ˘‚‰·›ÓÈÔ P/C POLYMER/CARBON FIBER COMPOSITE ¶ÔÏ˘ÌÂÚ¤˜ / ™‡ÓıÂÙÔ ˘ÏÈÎfi ·ÓıÚ·ÎÔÓ‹Ì·ÙÔ˜

SRSI SS/RADEL®/SILICONE ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / RADEL®/ ™ÈÏÈÎfiÓË

Ti/CoCrMo Τιτάνιο CoCrMo/ Κοβάλτιο-χρώμιο-μολυβδαίνιο

SRTA SS/RADEL®/Ti Al Nitride ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / RADEL®/ ¡ÈÙÚ›‰ÈÔ ÙÈÙ·Ó›Ô˘ ·ÏÔ˘ÌÈÓ›Ô˘

SS/SILICA GLASS Ανοξείδωτοσ χάλυβασ/ Γυαλί πυριτίου

Ti/HA Τιτάνιο/Υδροξυαπατίτησ SRSN SS/RADEL®/ Ti/UHMWPE/HA SILICONE/Ti Al Nitride ∆ÈÙ¿ÓÈÔ / ¶ÔÏ˘·Èı˘Ï¤ÓÈÔ ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜/ ˘ÂÚ˘„ËÏÔ‡ ÌÔÚÈ·ÎÔ‡ ‚¿ÚÔ˘˜ / ® RADEL /™ÈÏÈÎfiÓË / À‰ÚÔ͢··Ù›Ù˘ ¡ÈÙÚ›‰ÈÔ ÙÈÙ·Ó›Ô˘ ·ÏÔ˘ÌÈÓ›Ô˘ SS/Ti SS/RADEL®/ ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / ∆ÈÙ¿ÓÈÔ SILICONE/Ti Nitride SS/Al/SILICONE Ανοξείδωτοσ χάλυβασ/ ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / RADEL® / Σιλικόνη/ ∞ÏÔ˘Ì›ÓÈÔ / ™ÈÏÈÎfiÓË Νιτρίδιο τιτανίου

STA SS/Ti Al Nitride AÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / ¡ÈÙÚ›‰ÈÔ ÙÈÙ·Ó›Ô˘ ·ÏÔ˘ÌÈÓ›Ô˘

Si/NITINOL Σιλικόνη/Νιτινόλη S SS Ανοξείδωτο ατσάλι

S/U SS/ULTEM ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / Ultem

S/A SS/Al ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / ∞ÏÔ˘Ì›ÓÈÔ

T Ti Τιτάνιο και τα κράματά του

SS/SILICA GLASS/ PL/SILICONE Ανοξείδωτοσ χάλυβασ/ Γυαλί πυριτίου/Σιλικόνη SS/SILICA GLASS/ RADEL® /SILICONE Ανοξείδωτοσ χάλυβασ/Γυαλί πυριτίου/ RADEL® / Σιλικόνη SS/SILICA GLASS/ SILICONE Ανοξείδωτοσ χάλυβασ/ Γυαλί πυριτίου/Σιλικόνη

SBR SS/Ba/RADEL® ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / µ¿ÚÈÔ / RADEL®

S/R SS/RADEL® ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / RADEL®

S/P SS/PHENOLIC ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / º·ÈÓÔÏÈ΋ ¤ÓˆÛË

R/T POLYOLEFIN RUBBER/Ti ∫·Ô˘ÙÛԇΠÔÏ˘ÔÏÂÊ›Ó˘ / ∆ÈÙ¿ÓÈÔ

SS / WC / SILICONE Ανοξείδωτοσ χάλυβασ/ Καρβίδιο βολφραμίου/Σιλικόνη

T/A Ti/Al ∆ÈÙ¿ÓÈÔ / ∞ÏÔ˘Ì›ÓÈÔ

W/C Καρβίδιο βολφραμίου

S/PL SS/PL ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / ¶Ï·ÛÙÈÎfi

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S/SI SS/SILICONE ∞ÓÔÍ›‰ˆÙÔ˜ ¯¿Ï˘‚·˜ / ™ÈÏÈÎfiÓË

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