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Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion 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, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments. Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion. The system is composed of modular polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, sublaminar band cerclages, band connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.

The EGPS Navigated Instruments are indicated for use during the preparation and placement of Astura Medical screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The EGPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for precisely locating anatomical structures and for the special position of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. Use of the EGPS Navigated Instrument System is limited to use only with the Olympic and Masada spinal fixation systems (Olympic K153446, Olympic MIS K182239, Masada K231694).

Astura Medical EGPS Navigated Instruments are non-sterile, reusable instruments including a drill and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of associated Astura Medical screw implants. The instruments are manufactured from stainless steel per ASTM F899.

The DOMINION Expandable Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-Tl) and the thoracolumbar spine (T1-L5). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the cervical spine (C2-T1), DOMINION spacers are in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissues in the cervical degenerative disorders. These spacers 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. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. When used in the thoracolumbar spine (T1-L5), DOMINION spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The system is intended to be used with supplemental fixation that has been cleared by the FDA for use in the thoracolumbar spine (i.e. posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The Dominion Expandable Corpectomy system is a modular system comprised of Expandable Columns, Modular Endplates, and optional screws. The primary purpose of the Expandable Column is to provide mechanical support to the anterior column of the spine after a vertebral corpectomy is performed. The primary function of the Modular Endplates is to provide attachment points for the Expandable Column to the vertebral endplates. The screws are an optional device that can provide enhanced fixation to the vertebral endplates when desired. The system contains Inserters which allow the insertion and expansion of the Expandable Columns.

Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion 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, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediative patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolessent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments. Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The MASADA Modular Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of modular polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, sublaminar band cerclages, band connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.

The REUNION SI Joint System is indicated for skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Reunion Sacroiliac (SI) Joint Fusion System is a screw system designed to provide fixation across the sacroiliac joint to promote fusion. The screws are accompanied by a modular screw head that provides additional fixation points to the bone. A secondary screw option is a compression screw that does not affix to the modular heads. The system is supported by a comprehensive set of instruments to install the screw implants within the system.

The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated 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 great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability 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, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation. SIRION X must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine.

The Sirion Lateral Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: -Spinal trauma surgery, used in sublaminar or facet wiring techniques. -Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. -Spinal degenerative surgery, as an adjunct to spinal fusions. The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The OLYMPIC Deformity Band System is a system designed to stabilize a vertebrae during the fusion process. The system is composed of sublaminar bad cerclages and band connectors. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.

The EL CAPITAN Anterior Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). EL CAPITAN system implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The EL CAPITAN spacer and plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When used with anchors only the zero plate may be used and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (>20° lordosis), Oblique interbody devices and EL CAPITAN X must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine. The EL CAPITAN X spacer may only be used with titanium alloy screws.

The EL CAPITAN Anterior Lumbar Interbody Fusion devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The Spacers are a modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights, and the plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).

The El Capitan Anterior Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiosraphic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). El Capitan System implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (0) months of non-operative weatment prior to treatment with an intervertebral cage. The EL CAPITAN Spacer and Plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When used with anchors only the zero plate may be used and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (>20° lordosis) and the Oblique interbody devices must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine.

The El Capitan Anterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The Spacers are a 2-piece modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights, and the plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).

The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated 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 great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability 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, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.

The Sirion Lateral Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.