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The VADER® Pedicle System: The VADER® Pedicle 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. The VADER® Pedicle System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis) and spinal instability due to infection, surgical debridement, or decompression. The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery. VADER®one Pedicle System: The VADER ®one Pedicle 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The VADER®one Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System and VADER®one Pedicle System with additional connector components. The VADER® Pedicle System and VADER®one Pedicle System are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of: - Polyaxial cannulated, fenestrated pedicle screws, - Polyaxial, cannulated, pedicle screws, ● - Curved. straight. S-rods. J-rods. ● - Connectors . The VADER® Pedicle System and VADER®one Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

The icotec Anterior Cervical Plate 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 (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion. When used with the icotec Cervical Cage or the KONG®-C VBR System, the icotec Anterior Cervical Plate System is intended to stabilize the cervical (from C2 to T1) spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

The icotec Anterior Cervical Plate System consists of plates and screws intended for use in anterior cervical fixation from C2 to T1. The system is developed to allow for conventional ventral approaches to the cervical spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate tantalum markers per ASTM F560. The icotec Anterior Cervical Plate System is available in various plate lengths and with selftapping screws for the specific adaption to the patient's anatomy. The icotec Anterior Cervical Plates are 18 mm in width and come as 1- to 4-segmental implants with lengths ranging from 21 up to 94 mm. The plates are precontoured to fit patient anatomy. The screw holes in the plates are conical and threaded. The icotec Anterior Cervical Plate System self-tapping screws are available in diameters of 4.0 and 4.25 mm with lengths of 13 and 15 mm. The fully threaded bone screws have threaded conical heads to firmly lock into the plate. The conical threaded screw heads are designed to block pullout while screw angulation in the cranial direction prevents screws from penetrating through the lower end plate of the vertebral body.

icotec Cervical Cage: The icotec Cervical Cage is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with degenerative cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment. When used with the icotec Anterior Cervical Plate System, the icotec Cervical Cage is intended to stabilize the cervical spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscits, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression. icotec PLIF Cage: The icotec PLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g., pedicle screws). The device system is intended to be used with autograft. When used with the VADER® Pedicle System, the icotec PLIF Cage is intended to stabilize the lumbar spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression. icotec ETurn® TLIF Cage: The icotec ETurn® TLIF Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in sketally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by radios. The device system is designed for use without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g., pedicle screws). The device system is intended to be used with autograft. When used with the VADER® Pedicle System, the icotec ETurn TLIF Cage is intended to stabilize the lumbar spinal column as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

The icotec Interbody Cage System (i.e., icotec Cervical Cage, icotec PLIF Cage, and icotec ETurn® TLIF Cage) is an interbody cage system designed to restore the intervertebral height and to facilitate intervertebral body fusion of the spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and incorporate a rough titanium coating. The devices are intended to be used with supplemental spinal fixation. There is one type of cervical cage and two lumbar cages (i.e., PLIF and ETurn® TLIF) included in this portfolio. Each cage is provided sterile and is available in an assortment of heights, footprints, and/or lordosis angles to accommodate patient anatomy.

KONG®-TL VBR System devices are intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). When used in the thoracolumbar spine, the KONG®-TL VBR System is intended to be used with FDA-cleared supplemental fixation appropriate for the implanted level, including icotec Pedicle Screw Systems. These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are 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 thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graff used at the surgeon's discretion. When used with the VADER® Pedicle System, the KONG®-TL VBR System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression. KONG®-C VBR System devices are intended for use in the cervical spine (from C2 to T1) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. KONG®-C VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are 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, with bone graft used at the surgeon's discretion. When used with the icotec Anterior Cervical Plate System, the KONG®-C VBR System is intended to stabilize the cervical (from C2 to T1) spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

KONG®-TL VBR System: The KONG®-TL VBR System is a vertebral body replacement system for anterior stabilization of the thoracic and lumbar spine. This device serves as a replacement for vertebral bodies in tumorous and traumatic diseases which lead to instabilities in the anterior support or compression of neural structures or diseases that make an infection repair necessary. The KONG®-TL VBR System is intended for use with an additional dorsal or anterolateral fixation system (e.g., icotec Pedicle System). The KONG®-TL VBR System is a modular design featuring an expandable body, extensions, and end plates with various heights, widths, and angles. The system consists of expandable body structures that range in height from 19 to 96 mm, have a diameter of 19 mm and surface treads/spikes on its cranial and caudal end plate surfaces that serve to guide and anchor the implant. The system also consists of rectangular and round end plate configurations. The end plate round configuration has a geometry that ranges from 0°, 4°, 8° and 12° and size that ranges from 26 to 43 mm. The end plate rectangular configuration has geometry that ranges from 0°, 4°, 8° and 12° and size that ranges from 33 to 52 mm. The end plates are locked with a screw onto the main body. The tread surfaces and spikes help to improve primary fixation stability of the end plates. The large contact surface of the end plates reduces the risk of migration. The screw for fixation of the end plates to the body has a length of 6 mm and a thread size of M8. The KONG®-TL VBR System is made of BlackArmor® material, a carbon fiber reinforced polyetheretherketone (Carbon/PEEK) composite. The BlackArmor® material is a combination of continuous, high strength carbon fiberreinforced PEEK and icotec's composite flow molding (CFM) process. The result is a non-metallic implant component with an interwoven 3D fiber architecture that provides strength and endurance. BlackArmor® is radiolucent in all diagnostic imaging modes (MRI, CT and X-ray) and will therefore not create imaging artifacts. Embedded tantalum markers (per ASTM F560) ensure the required radiologic visibility of the implant during surgery and follow-up. The KONG®-TL VBR System incorporates a rough cp-titanium coating (per ASTM F1580), designed to improve direct bone apposition. The partially hollow geometry of the implants (endplates and extension) allows them to be packed with bone graft. The implants are supplied sterile and are available in a variety of heights, footprints and anatomical shapes to accommodate patient anatomy. KONG®-C VBR System: The KONG®-C VBR System is a vertebral body replacement system for anterior stabilization of the cervical spine. This device serves as a replacement for vertebral bodies in tumorous and traumatic diseases which lead to instabilities in the anterior support or compression of neural structures or diseases that make an infection repair necessary. The KONG®-C VBR System is a modular design with various heights, widths, and angles. The system consists of a lordotic body structure that ranges in height from 5 - 55mm with a width and depth of 13mm, and surface treads on its cranial and caudal end plate surfaces that serve to guide and anchor the implant. The overall height of the VBR device including body and end plates ranges from 16 to 66 mm. The end plates have a geometry that range from 0 to 6° and are manufactured in the following sizes: 14 x 13mm, 16 x 13mm. and 18 x 14mm. The tread surfaces help to improve primary fixation stability of the end plates. The large contact surface of the end plates reduces the risk of migration. The screw to secure the end plates to the body has a length of 7 mm and a thread size of M6. The KONG®-C VBR System is composed of BlackArmor® material, a carbon fiber reinforced polyetheretherketone (Carbon/PEEK) composite. The BlackArmor® material is a combination of continuous, high strength carbon fiberreinforced PEEK and icotec's composite flow molding (CFM) process. The result is a non-metallic implant component with an interwoven 3D fiber architecture that provides strength and endurance. BlackArmor® is radiolucent in all diagnostic imaging modes (MRI, CT and X-ray) and will therefore not create imaging artifacts. Embedded tantalum markers (per ASTM F560) ensure the required radiologic visibility of the implant during surgery and follow-up. The KONG®-C VBR System incorporates a rough cp-titanium coating (per ASTM F1580), designed to improve direct bone apposition. The implants are supplied sterile and are available in a variety of heights, footprints and anatomical shapes to accommodate patient anatomy.

The VADER® Pedicle 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. The VADER® Pedicle System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscits, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression. The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight, S-rods and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

icotec Navigation Instruments are intended to be used during the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System Navigated Instruments. icotec's VADER® Pedicle System Navigated Instruments are reusable instruments used for the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed for use with navigation system Medtronic StealthStation® in combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®II clamps and arrays. The VADER® Pedicle System Navigated Instruments include awls, probes, taps, drivers and adapters. The VADER® Pedicle System Navigated Instruments are to be used with the FDAcleared icotec pedicle screws cleared under K222789. K200596. K193423 and K190545.

The VADER® Pedicle 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery. When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight, S-rods and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

The icotec Anterior Cervical Plate 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 (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion.

The icotec Anterior Cervical Plate System consists of plates and screws intended for use in anterior cervical fixation from C2 to T1. The system is developed to allow for conventional ventral approaches to the cervical spine. The icotec Anterior Cervical Plate System is available in various plate lengths and with selftapping screws for the specific adaption to the patient's anatomy. The icotec Anterior Cervical Plates are 18mm in width and come as 1- to 4-segmental implants with lengths ranging from 21 up to 94mm. The plates are precontoured to better fit patient anatomy. The screw holes in the plates are conical and threaded. The icotec ACP self-tapping screws are available in diameters of 4.0 and 4.25mm with lengths of 13 and 15mm. The fully threaded bone screws have threaded conical heads to firmly lock into the plate. The conical threaded screw heads are designed to block pullout while screw angulation in the cranial direction prevents screws from penetrating through the lower end plate of the vertebral body.

When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® one pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. The VADER® Pedicle 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws 6.0 are 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, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are limited to the use at spinal levels where the structural integrity of the spine is not severely compromised. The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

The purpose if this Traditional 510(k) is to seek marketing clearance for the G21 Cement (V-Steady and V-Fast Bone Cements) to be used with the VADER® Pedicle System and to seek clearance for the VADER® Pedicle System. V-Steady and V-Fast are polymethylmethacrylate (PMMA) based bone cements formulated to perform percutaneous vertebral augmentation procedures, such as vertebroplasty or kyphoplasty. Bone cements are self-curing systems consisting of liquid and powder components: - The powder component is constituted of PMMA beads shaped particles containing the initiator benzoyl peroxide required for starting initiating the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization). - The liquid component comprises the monomer, methylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage. The specific content of PMMA and benzoyl peroxide is slightly different between the two cements conferring upon them specific properties. V-Steady bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time. The V-Fast has a low initial viscosity and a long working time allowing to work extremely carefully especially when a good time margin before polymerization is required. Both the liquid and powder components are supplied sterile. The sterile-filtered monomer component is supplied in an amber glass ampoule (10 ml) and comes in a blister pack sterilized by ethylene oxide. The polymer powder component is supplied in a double sterile packaging. The sterilization process is ethylene oxide and it has been properly validated. Preparation and application procedures of the subject devices are detailed within the labeling as Mixing Phase, Waiting Phase, Application Phase, Setting/Hardening Phase. The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

Cervical KONG®-C VBR System devices are intended for use in the cervical spine (from C2 to T1) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. KONG®-C VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA. These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are 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, with bone graft used at the surgeon's discretion. Thoracolumbar KONG®-TL VBR System devices are intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). When used in the thoracolumbar spine, the KONG®-TL VBR System is intended to be used with FDA-cleared supplemental fixation appropriate for the implanted level, including icotec Pedicle Screw Systems. These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are 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 thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The KONG®-TL VBR System and the KONG®-C VBR System are vertebral body replacement systems designed to improve the stability of the cervical and thoracolumbar spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/ PEEK. BlackArmor®) and incorporate a rough titanium coating (Ti-TT®). The devices are intended to be used with supplemental spinal fixation. Each implant is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.