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The InTice™-C Porous Ti Cervical Interbody System is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks non-operative treatment with the InTice™-C Porous Ti Cervical Interbody System. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e. posterior cervical screw and rod systems and anterior cervical plate systems).

The InTice™-C Porous Ti Cervical Interbody System is an intervertebral fusion device, generally box or oval-shaped, and available in a variety of shapes and sizes to accommodate the individual patient anatomy. The implants are made from highly porous commercially pure titanium (CP-TI Grade 2) that complies with ASTM F67. The material is formed into an integrated titanium scaffold, OsteoSync™ Ti (manufactured by Sites Medical), which assists in securing the implant in the intervertebral space. The formed titanium material has a porosity created by a designed hole pattern, and the superior and inferior surfaces of the implant have a tooth pattern to help resist implant dislodgement or expulsion once placed in its desired location. The hollow center of the implant allows the device to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The single use implants are provided sterile, and should not be reused under any circumstances. The system does not contain software/firmware or electrical equipment.

The X-spine Cortical Bone Screw System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications: - Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies - Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion - Spondylolisthesis - Trauma (i.e. fracture or dislocation) - Spinal stenosis - Deformities or curvatures (i.e. scoliosis, kyphosis) - Spinal tumor - Pseudoarthrosis, and/or - Failed previous fusion

The X-spinesw Cortical Bone Screw System consists of pedicle screws, rods, cross connectors, and associated instruments. Various forms and sizes of these implants are available so that adaptations can be made to take into account the pathology and anatomy of an individual patient. The system implant components are manufactured from Ti6Al4V ELI, a titanium based alloy which complies with ASTM F136. Alternatively, rods are also offered manufactured from cobalt chromium alloy which complies with ASTM F1537. The single use only implants are provided non-sterile, and should not be reused under any circumstances. The system does not contain software/firmware or electrical equipment.

The Calix® Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 – S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The X-spine Calix® Lumbar Spinal Implant System is an intervertebral fusion device for use with bone graft, designed for surgical placement between adjacent vertebrae of the lumbar spine as an adjunct to fusion. The X-spine Calix® Lumbar Spinal Implant System is a generally hollow box or oval shaped device manufactured from Invibio PEEK-Optima™ LT1 per ASTM F2026. The device contains an array of holes located throughout its geometry as well as teeth on the superior and inferior surfaces to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without a medical grade commercially pure titanium (CP Ti) plasma coating (per ASTM F1580) on the superior and inferior surfaces of the device. The hollow center of the implant allows the device to be packed with bone graft: autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, The single use implants are supplied in several width, height and lordosis options to accommodate variations in patient anatomy and differing pathologies. The devices contain radiographic markers made from tantalum per ASTM F560 to aid in final placement verification. Plasma coated implants are provided clean and sterile. Nonplasma coated implants and instruments are provided non-sterile. All implants are intended for single use only, and should not be reused under any circumstances. The system does not contain software/firmware.

The IRIX-A™ Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin 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 had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The IRIX-A™ System is intended to be used with autograft and/or allograft comprised of cancellous bone graft material, and is to be used with three titanium alloy screws included as part of the system. Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

The IRIX-A™ Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The IRIX-A™ implant is manufactured from both titanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. The device is secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes, and screws are offered in multiple lengths to adjust for variations in patient anatomy. The spacers of the IRIX-A™ System are supplied clean and STERILE. The screws and accompanying instruments of the IRIX™-A System are provided clean and non-sterile. The system does not contain software/firmware or electrical equipment.

The Calix-C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks of non-operative treatment with the Calix-CTM Cervical Interbody Spacer. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., posterior cervical screw and rod systems and anterior cervical plate systems).

The Calix-C™ Cervical Interbody Spacer is an intervertebral fusion device, generally box or oval-shaped, that has various holes throughout its geometry. The device body is made from Invibio PEEK-Optima™ (polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560. Superior and inferior surfaces of the device have teeth to help prevent implant dislodgement or expulsion once placed in its desired location. The implants are available with or without titanium plasma coating on the superior and inferior surfaces of the device. The plasma coating is made from medicalgrade titanium per ASTM F1580. The hollow center of the implant allows the device to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The system does not contain software/firmware.

The Spider® Cervical Plating System is intended for anterior fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following: degenerative disc disease (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal tumors, deformity (e.g., kyphosis, lordosis, scoliosis), pseudarthrosis, and/or failed previous fusion.

The Spider® Cervical Plating System consists of titanium alloy (Ti 6Al 4V ELI) anterior cervical plates and bone screws, allowing for fixation between one and four intervertebral segments. The plates attach to the anterior portion of the vertebral body of the cervical spine, levels C2 to C7. The titanium alloy conforms with ASTM F136, Standard Specification Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) alloy for Surgical Implant Applications (UNS R56401). The system does not contain software/firmware.

The Butrex® Lumbar Buttress Plating System is intervertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

The Butrex® Lumbar Buttress Plating System consists of a variety of shapes and sizes of bone plates and screws. The Butrex plates contain two sockets for screw placement on one end and a buttressing surface on the other end. The system is intended for anterior screw fixation to the L1 to S1 spine. The components are manufactured from titanium alloy (Ti 6Al 4V ELI). The titanium conforms with ASTM F136, Standard Specification Wrouqht Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) alloy for Surqical Implant Applications (UNS R56401). A separate intervertebral fixation construct, such as posterior pedicle screws, must be used for proper stabilization to be achieved. The system does not contain software/firmware.

The Xsert™ Lumbar Expandable Interbody System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The Xsert™ Lumbar Expandable Interbody System of X-spine Systems, Inc. is an expandable interbody system used to provide structural stability in skeletally mature individuals following discectomy. The Xsert™ Lumbar Expandable Interbody System will consist of spacers offered in various shapes and sizes, and their heights can be intra-operatively expanded to fit the anatomical needs of a wide variety of patients. These spacers are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft material and have features on the superior and inferior surfaces of each device to grip the endplates of the adjacent vertebrae to resist expulsion. The implant components of the system are manufactured from medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F-136. All implants will be provided clean and sterile, are intended for single use only, and should not be reused under any circumstances. A series of manual surgical instruments intended to assist with the insertion and placement of the implants is included in an instrument tray, which is used for instrument sterilization and storage.

The Irix-C Cervical Integrated Fusion System is a stand-alone cervical fusion device intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies). Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral fusion device.

The Irix-C Cervical Integrated Fusion System is a stand-alone intervertebral fusion device designed to restore biomechanical height and act as an aid in fusion of the cervical spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the device. The Irix-C implant will be manufactured in either a composite construction of titanium alloy (Ti6AI4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. The intervertebral fusion device is intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The device is then secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6AI4V) per ASTM F136. The devices are available in various sizes, and screws are offered in multiple lengths to adjust for variations in patient anatomy. The single-use implants are provided clean and non-sterile. These devices are intended to be sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave. A series of manual surgical instruments, provided clean and non-sterile, intended to assist with the insertion and placement of the implants, is included in an instrument tray, which is used for instrument sterilization and storage. The system does not contain software/firmware.

The intended use of the Certex Spinal Fixation System is 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 to 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 and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The X-spine Certex Spinal Fixation System is 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. The X-spine Certex Spinal Fixation System can be linked to X-spine Fortex® Pedicle Screw System and X-spine Xpress™ Minimally Invasive Pedicle Screw System with rod-to-rod connectors and transition rods.

The Certex Spinal Fixation System consists of polyaxial screws, hooks, rods, occipital plates, occipital bone screws, cross bar connectors, lateral offset connectors and rod-to-rod connectors. System components can be connected and locked together to promote fusion of the occipitocervico-thoracic spine (Occiput-T3). System components are offered in various sizes and configurations to accommodate variations in pathology and individual patient anatomy. All Certex Spinal Fixation System components are manufactured from Titanium alloy (Ti6AI4V) in accordance with ASTM F136. The purpose of this submission is to expand the indications of the Certex Spinal Fixation System to include cervical pedicle screw indications.