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ASTRA and AVANT Navigated Reusable Instruments are indicated for preparation and placement of SpineCraft ASTRA Spine system pedicle screws during thoracolumbar sacroiliac spinal surgery to assist surgeon in precisely locating anatomical structures in either open, minimally invasive procedures, or percutaneous, procedures. ASTRA and AVANT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® System S8 (V1.2.0), 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. Use of the ASTRA and AVANT Navigated Reusable Instruments is limited to use only with ASTRA Spine System implants. ASTRA-OCT Navigated Reusable instruments are indicated for preparation and placement of SpineCraft ASTRA-OCT Spine screws during cervico-thoracic spinal surgery to assist surgeon in precisely locating anatomical structures in open procedures. ASTRA-OCT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® System S8 (V1.2.0), 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. Use of the ASTRA-OCT Navigated Reusable Instruments is limited to use only with ASTRA-OCT Spine System implants.

The ASTRA, AVANT and ASTRA-OCT Navigation instruments are non-sterile, reusable surgical instruments designed for compatibility with the Medtronic NavLock Trackers and to ultimately provide seamless interaction with the Medtronic StealthStation® System. The ASTRA and AVANT Navigation instruments are for use with ASTRA Spine System pedicle screws and the ASTRA-OCT Navigation instruments are for use with ASTRA-OCT Spine System pedicle screws. The instruments are manufactured from medical grade stainless steel. The ASTRA-OCT navigation instruments are available in same or similar diameters and lengths as the corresponding predicate Medtronic navigated instruments. This includes awls, probes, drill bits, taps and screwdrivers.

The ASTRA Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar, and sacral spine. The ASTRA Spine System is indicated for non-cervical (T)-S2/Ilium) pedicle fixation and non-pedicle fixation in skeletally mature patients as an adjunct to following indications: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture and/or dislocation); spinal stenosis; deformities (scoliosis, lordosis and/or kyphosis); spinal tumor; and failed previous fusion (pseudo-arthrosis). When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ASTRA Spine System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the ASTRA Spine System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The ASTRA fenestrated screw when used with other components of the ASTRA Spine System is indicated to provide the surgeon with an open or minimally invasive approach for posterior spinal surgery. The ASTRA fenestrated screw is intended to be used with saline or radiopaque dye.

The ASTRA Spine System consists of Ø 5.5mm, Ø 6.0mm and Ø 6.2mm longitudinal, lordosed, contoured and revision rods, pedicle screws (monoaxial, and uniplanar), cannulated pedicle screws (standard and reduction monoaxial, standard, reduction & extended tab polyaxial and standard & reduction uniplanar), fenestrated screws (standard, reduction & extended tab standard & reduction uniplanar), hooks (standard & reduction), lateral iliac connectors, rod-to-rod connectors and transverse (cross) connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy. The safety and effectiveness of the ASTRA fenestrated screw has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g.,osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye. Materials: Titanium alloy per ASTM F136 and CoCr alloy per ASTM F1537

The ORIO-Ti cervical intervertebral body fusion cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six (6) weeks of non-operative treatment with an intervertebral cage. ORIO-Ti cervical intervertebral body fusion implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. ORIO-Ti cervical intervertebral body fusion implant is to be used with supplemental fixation that has been cleared for use in the cervical spine. The ORIO-Ti lumbar intervertebral body fusion cage is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six (6) months of non-operative treatment. ORIO-Ti lumbar intervertebral body fusion implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral, or lateral approach. The ORIO-Ti lumbar intervertebral body fusion implants are to be used with supplemental fixation that have been cleared for use in the lumbosacral spine.

The subject devices are intervertebral body fusion devices for use in cervical lumbar spinal surgery. They may also be referred to as interbody fusion devices or interbody cages. The devices are generally boxshaped or trapezoidal shaped with windows or pockets in their design to allow for the placement of autograft or allogenic bone graft. The ORIO-Ti Cage System is a Titanium alloy interbody fusion system comprised of various device configurations based on surgical approach and patient anatomy, and may be implanted via one of the following approaches: as a single device via an anterior cervical (ACDF), bilaterally in pairs via a posterior (PLIF) approach; as a single device via a transforaminal (TLIF) approach; or as a single device via an anterior (ALIF) approach. The exterior of the devices has "teeth" on the superior and inferior surfaces to help prevent the devices from migrating once they are implanted.

The ASTRA Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudo-arthrosis). The ASTRA Spine System is also a sacral/iliac screw fixation system of the 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 (pseudo-arthrosis). When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ASTRA Spine System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the ASTRA Spine System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The subject ASTRA Spine System is top loading, multiple components, posterior system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to match the patient's anatomy more closely. The subject ASTRA Spine System includes the pediatric use in the indications and other labeling updates to provide more clarity to the device insert.

The ASTRA-OCT Spine System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3): - · Traumatic spinal fractures and/or Traumatic dislocations; - Instability or deformity; - · Failed previous fusions (e.g. pseudoarthrosis); - · Tumors involving the cervical/thoracic spine: and · Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The ASTRA-OCT Spine System implants are also 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. In order to achieve additional levels of fixation, the ASTRA-OCT Spine System rods may be connected to other occipital cervical thoracic or thoracolumbar stabilization rod systems ranging in diameter from 3.5mm, including the ASTRA or APEX Spine Systems, using corresponding connectors.

The ASTRA-OCT Spine System consists of a series of polyaxial screws, occipital screws, occipital plates, hooks, rods, lateral connectors, rod-to-rod connectors, set screws, and cross connectors. Materials: Titanium alloy per ASTM F136 CoCr allov per ASTM F1537

The APEX-DL Spine System with APEX Spine System Components is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: 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 (pseudoarthrosis). The APEX-DL Spine System with APEX Spine System Components is 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, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained. The APEX-DL Spine System with APEX Spine System Components is also a sacraliliac screw fixation system of the non-cervical 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 (pseudo-arthrosis). When used in a percutaneous posterior approach with AIM MIS instrumentation, the APEX-DL Spine System with APEX Spine System Components is intended for non-cervical pedicle fixation for 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), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine. When used for posterior non-cervical pediatic patients, the APEX-DL Spine System implants with APEX Spine System Components are indicated as an adjunct to treat adolescent idiopathic scoliosis. The APEX DL Spine System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The APEX-DL Spine System includes Monoaxial, Uniplanar, and Polyaxial Double Lead Thread Screws in the cannulated and non-cannulated versions and in regular and reduction (extended tab) versions. APEX-DL Spine System is a low profile thoracolumbar implant for use with wide range of patient statures. The APEX-DL Spine System Polyaxial screws feature a friction head, which is designed to provide precise reduction mechanism as a result of easier rod capturing. The APEX-DL Spine System also includes Lordosed Percutaneous Rods. The APEX-DL Spine System is compatible with the APEX Spine System 5.5mm and 6.0mm rods, hooks, side-by-side connectors, iliac connectors, cross connectors, and washers.

The ASTRA System is intended to provide immobilization 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudo-arthrosis). The ASTRA Spine System is 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, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained. The ASTRA System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis). When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for 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), spinal stenosis, curvatures (i.e., scoliosis, kyphosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

The ASTRA Spine System is a top loading, multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy. Materials: Titanium alloy CoCr alloy

The VELOX Anterior Cervical Plate System is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fision of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: · degenerative disc disease (as defined by neck pain of discogenion of the disc confirmed by patient history and radiographic studies), - · spondylolisthesis, · trauma (i.e. fractures or dislocations), • tumors, · deformity, · pseudarthrosis. · failed previous fusion, · spinal stenosis.

The VELOX Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The VELOX anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The VELOX plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the VELOX Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths.

The APEX Spine System is intended to provide immobilization 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudoarthrosis). The APEX Spine System is 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, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained. The APEX Spine System is also a sacraliliac screw fixation system of the non-cervical 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 (pseudo-arthrosis). When used in a percutaneous posterior approach with AIM MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation for 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), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

The purpose of this submission is to add x-large and uniplanar pedicle screws, open iliac connectors and open-closed side-by-side connectors to the APEX Spine System. The APEX Spine System X-Large Screws are similar to the APEX screws and are available in a variety of diameters and lengths and can be used of the components of the previously cleared APEX Spine System. The APEX Uniplanar Pedicle Screw is similar in principle to the APEX Polyaxial Pedicle Screw; however the design restricts motion to the sagittal plane. The Open Iliac Connectors and Open-Closed Side-by-Side Connectors are utilized when pedicle screws are not vertically aligned.

The APEX Spine System is 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. Iumbar, and sacral spine: 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 (pseudoarthrosis). The APEX Spine System is 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, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained. The APEX Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with deqeneration 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 (pseudo-arthrosis). When used in a percutaneous, posterior approach with AIM Spine MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation for 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), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed prvious fusion in skeletally mature patients . Levels of fixation are for the thoracic. lumbar and sacral spine.

The purpose of this submission is to add cannulated screws to the APEX Spine System and add indications for use of the APEX Spine System in a posterior percutaneous approach and product code NKB. The APEX Spine System Cannulated Screws have exactly the same geometry of the APEX screws with the addition of a cannulation. The screws are available in a variety of diameters and lengths and can be used with the components of the previously cleared APEX Spine System. Materials: Titanium alloy per ASTM F136 Function: The APEX Spine System is indicated for 1)non-cervical spinal fixation devices intended for posterior, non-pedicle fixation, 2)for non-cervical pedicle screw fixation and 3)hook fixation systems of the non-cervical spine, 4)for degenerative disc disease.