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The CarboClear® Hybrid Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at up to three levels from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of nonoperative treatment. The CarboClear® Hybrid Pedicle Screw System is intended to be used with intervertebral body fusion device/s implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The CarboClear® Hybrid Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The CarboClear® Hybrid Pedicle Screws, including CarboClear® Hybrid Fenestrated Screws, are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy tulip. Their threaded portion is encased within a thin titanium shell. They are used with a compatible titanium alloy set screw, and with CarboClear CFR-PEEK rods. The implants may include tantalum markers. CarboClear titanium alloy rod is also offered. The implants are supplied sterile, and are intended for single use. The CarboClear® Hybrid implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.

The CarboClear® X Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at up to three levels from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® X Pedicle Screw System is intended to be used with intervertebral body fusion device/s implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The CarboClear® X Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The implants include pedicle screws, rods, and a locking element (set screw). They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. The implants may include tantalum markers. Titanium alloy rod is also available. The implants are supplied sterile, and are intended for single use. The CarboClear® X implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach.

CarboClear® Hybrid Pedicle Screw System (Oncological) The CarboClear® Hybrid Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CarboClear® Hybrid Pedicle Screw System (DDD) The CarboClear® Hybrid Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Hybrid Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. CarboClear® Hybrid Navigated Instruments CarboClear® Hybrid Navigated Instruments are intended to be used during the preparation and placement of CarboClear® Hybrid Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® Hybrid Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. CarboClear® Hybrid Fenestrated Pedicle Screw System When used in conjunction with High V+® Bone Cement, the CarboClear® Hybrid Fenestrated Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CarboClear® Hybrid Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised. When used without cement, the CarboClear® Hybrid Fenestrated Pedicle Screws are intended: (a) to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. (b) to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Hybrid Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. High V+® Bone Cement When used in conjunction with the CarboClear® Hybrid Fenestrated Pedicle Screw System, High V +® Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised. CarboClear® X Fenestrated Pedicle Screw System When used in conjunction with High V+® Bone Cement, the CarboClear® X Fenestrated Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CarboClear® X Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised. When used without cement, the CarboClear® X Fenestrated Pedicle Screw System is intended: (a) to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. (b) to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® X Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. High V+® Bone Cement When used in conjunction with the CarboClear® X Fenestrated Pedicle Screw System, High V+® Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

The CarboClear® Hybrid Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The CarboClear® Hybrid Pedicle Screws, including CarboClear® Hybrid Fenestrated Screws, are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy tulip. Their threaded portion is encased within a thin titanium shell. They are used with a compatible titanium alloy locking element, and with CarboClear X CFR-PEEK rods and trans-connectors. The implants may include tantalum markers. CarboClear X titanium alloy rod is also offered. The implants are supplied sterile, and are intended for single use. The CarboClear® Hybrid implants may be implanted in an open approach or using a minimally invasive surgery (MIS) approach. The CarboClear® Hybrid Navigated Instruments are manually operated instruments, intended to be used with Medtronic's StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® Hybrid pedicle screws, respectively, during spinal surgery. The CarboClear® Hybrid Fenestrated Pedicle Screws and CarboClear® X Fenestrated Pedicle Screws are cannulated polyaxial pedicle screws in various dimensions, with lateral fenestrations near screws' distal tip, which allow controlled delivery of polymethylmethacrylate (PMMA) bone cement (High V+® Bone Cement) into the vertebral body in oncological patients. These implants may also serve as traditional cannulated pedicle screws when used without bone cement. The High V+ Bone Cement is a self-curing, high viscosity, radiopaque PMMA based bone cement. It is provided sterile in two components: 20 grams of powder and 8.6 grams of liquid. The powder component consists of polymethylmethacrylate, with barium sulfate and hydroxyapatite as radiopacifier, and benzoyl peroxide as an initiator. The liquid component comprises methylmethacrylate monomer, with N.N-dimethyl-p-toluidine as a promoter, and hydroquinone as a stabilizer. The powder and liquid components are mixed into homogenous paste, to initiate the polymerization reaction.

The CarboClear® Posterior Cervical Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear® Posterior Cervical Screw System ("CarboClear® System") is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The CarboClear® System is a posterior, cervical screw fixation system, intended to provide immobilization and stabilization of cervical spinal segments in oncological patients. The CarboClear® System implants include posterior screws, rods and locking elements (set screw). The implants are made mainly of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion and the spherical head of the screw are encased within a thin titanium shell, and may include a tantalum marker.

The CarboClear® Pedicle Screw System is intended to provide rigid immobilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment. The CarboClear® Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/ or allogenic bone graft comprised of cancellous and/or corticocancellous bone graff.

The CarboClear® Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The CarboClear® implants include pedicle screws, rods and locking elements. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. The implants include tantalum markers. The implants are supplied sterile, and are intended for single use.

The CarboClear® X Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CarboClear® X Navigated Instruments are intended to be used during the preparation and placement of CarboClear® X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® X Navigated Instruments are designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. When used in conjunction with High V+ ® Bone Cement, the CarboClear® X Fenestrated Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CarboClear® X Fenestrated Pedicle Screw System augmented with High V+® Bone Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised. When used in conjunction with the CarboClear® X Fenestrated Pedicle Screw System, High V+® Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. High V+® Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.

The CarboClear® X Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The implants for minimally invasive surgical procedures include pedicle screws, rods, and a set screw (locking element). They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell. Implants may include tantalum markers. The implants are supplied sterile, and are intended for single use. CarboClear® X Navigated Instruments are manually operated, instruments intended to be used with the Medtronic StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® X pedicle screws during spinal surgery. The CarboClear® X Fenestrated Pedicle Screw System consists of cannulated polyaxial pedicle screws in various dimensions, with lateral fenestrations near the screws' distal tip, which allow controlled delivery of polymethylmethacrylate (PMMA) bone cement (High V+® Bone Cement) into the vertebral body. The Screws are implanted with the components of the CarboClear® X Pedicle Screw System. The CarboClear® X Fenestrated Screw System is made of carbon fiberreinforced polyetheretherketone (CFR-PEEK). The threaded portion of the screws is encased within a thin titanium shell, and includes a small tantalum marker. The CarboClear® X Fenestrated Screw System is supplied sterile, and is intended for single use. High V+® Bone Cement is self-curing, high viscosity, radiopaque PMMA based bone cement. It is provided sterile in two components: 20 grams of powder and 8.6 grams of liquid. The powder component consists of polymethylmethacrylate, with barium sulfate and hydroxyapatite as radiopacifier, and benzovl peroxide as an initiator. The liquid component comprises methylmethacrylate monomer, with N.N-dimethyl-p-toluidine as a promoter, and hydroquinone as a stabilizer. The powder and liquid components are mixed into homogenous paste, to initiate the polymerization reaction.

The CarboClear® X Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CarboClear® X Navigated Instruments are intended to be used during the preparation and placement of CarboClear® X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® X Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The CarboClear X Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The implants include pedicle screws, rods, a set screw and transverse connectors. They are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell, and includes a small tantalum marker. The implants are supplied sterile, and are intended for single use. CarboClear® X Navigated Instruments are reusable, manually operated, instruments, including probes, bone taps and a screwdriver. These instruments are intended to be used with the Medtronic StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear® X Pedicle Screws during spinal surgery.

The CarboClear® X Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear X Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The implants include pedicle screws, rods, locking components (a set screw and a nut) and transverse connectors. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell, and includes a small tantalum marker. The implants are supplied sterile, and are intended for single use.

The CarboClear® Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CarboClear® II Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The CarboClear® and CarboClear® II Pedicle Screw Systems are composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants. The implants include pedicle screws, rods, locking elements and transverse connectors. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell, and includes a small tantalum marker. The implants are supplied sterile, and are intended for single use.

CarboClear® Navigated Instruments are intended to be used during the preparation and placement of CarboClear® Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear® Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CarboClear® Navigated Instruments are reusable, manually operated, instruments, including probes, bone taps and a screwdriver. These instruments are intended to be used with the Medtronic StealthStation® Navigation System, to assist surgeons in precisely locating anatomical structures for preparation and placement of CarboClear Pedicle Screws during spinal surgery.