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The Curiteva Porous PEEK Standalone ALIF devices are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Curiteva Porous PEEK Standalone ALIF spacer is an interbody fusion device to be used with three titanium alloy screws or anchors. When used with screws, the system is a standalone interbody fusion device. When used with anchors, the system is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (>20° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The Curiteva Porous PEEK ALIF devices are intended for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The system spacers are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.

The Curiteva Porous PEEK Standalone ALIF System implants are provided sterile or non-sterile, are single-use devices, and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The subject system consists of interbody spacer implants that are generally box-shaped with an open central corridor to permit packing with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The system also provides screws and anchors that can be inserted through the anterior portion of the spacers into adjacent vertebral bodies for bony fixation. The Curiteva Porous PEEK Standalone ALIF System implants are manufactured from implant-grade PEEK (per ASTM F2026), Titanium alloy (per ASTM F136), and Tantalum (per ASTM F560). All Porous PEEK interbody spacers are additionally surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The Curiteva Porous PEEK Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Porous PEEK Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The Curiteva Porous PEEK Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary. All system components are manufactured from Titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026. The Curiteva Porous PEEK Laminoplasty implants are sterile, single-use devices and available in a variety of different sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants have solid and porous PEEK regions. The Curiteva Porous PEEK Laminoplasty implants are manufactured from implant-grade PEEK (per ASTM F2026). Each porous PEEK implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The Curiteva Thoracolumbar Plate System Two Hole and Four Hole Plates are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability, or via the anterior surgical approach below the bifurcation of the greatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation is achieved. The Curiteva Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-SI ) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The Curiteva Thoracolumbar Plate System is an internal fixation device for spinal surgery that consists of various configurations of spinal plates and bone screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. All system implants are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The Curiteva Porous PEEK Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 - S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment with the device.

The Curiteva Porous PEEK Lumbar Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally rectangle-shaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense outer ring with a porous structure lining the central graft corridor. The lateral sides of the implant may contain additional porous structures to allow for improved vascularization of the graft site to aid in fusion. The Curiteva Porous PEEK Lumbar Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136). Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick.

The Curiteva Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Laminoplasty System is used to hold or buttress the allograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The Curiteva Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary. All system components are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026.

The Curiteva Porous PEEK Cervical Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Curiteva Porous PEEK Cervical Interbody Fusion System is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Curiteva Porous PEEK Cervical Interbody Fusion System implants are sterile, single-use devices and available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally boxshaped with an open central corridor to permit packing with bone graft to facilitate fusion. The implants have a dense central ring with a porous structure lining the vertical graft corridor and on the superior and inferior surfaces of the construct. Each implant has been surface treated with a hydroxyapatite (HA) coating that is approximately 20nm thick. The Curiteva Porous PEEK Cervical Interbody Fusion System implants are manufactured from implant-grade PEEK (per ASTM F2026) with Titanium alloy markers (per ASTM F136).

The Curiteva Navigation System is intended to be used during the preparation and placement of Curiteva screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Curiteva Navigation System is specifically 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 Curiteva Navigation System instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System S7 v2.1.0 and S8 v1.2.0 (1.2.0-20) to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Curiteva screws. The Curiteva Navigation System includes awls, probes, taps, drills, and drivers. The Curiteva Navigation System instruments are to be used with the Curiteva Pedicle Screw System or the Curiteva Sacroiliac Joint Fusion System, as specified. All instruments are made of stainless steel per ASTM F899. The Curiteva Navigation System instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.

The Curiteva Sacroiliac Joint Fusion System is intended for sacroiliac (SI) joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Curiteva Sacroiliac Joint Fusion System consists of screws in various diameters, lengths and thread configurations to accommodate variations in patient anatomy. The screws are designed to be implanted across the sacroiliac joint to stabilize and aid in the fusion of the sacroiliac joint. Optional washers are included to aid in the distribution of load across the bone surface directly apposing the screw head. The Curiteva Sacroiliac Joint Fusion System implants are manufactured from medical-grade titanium alloy in accordance with ASTM F136. All system implants are intended for single use only and should not be reused under any circumstances.

The Curiteva Pedicle Screw System is intended for posterior, non-cervical pedicle screw fixation (T1-S2/ilium) and hook fixation (T1-L5) in skeletally mature patients as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor, stenosis, pseudarthrosis and/or failed previous fusion. The Curiteva Pedicle Screw System is intended to be used with autograft and/or allograft.

The Curiteva Pedicle Screw System is a thoracolumbar and/or sacral spine fixation system for spinal surgery that consists of a variety of screws, rods, set screws, crosslink connectors, rod connectors, and hooks. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The Curiteva Pedicle Screw System implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Select rods are also available in medical grade Cobalt Chromium alloy (per ASTM F1537). All implants are intended for single use only and should not be reused under any circumstances.