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EIT Cellular Titanium® Cervical Cage: The EIT Cellular Titanium® Cervical Cages with a microscopic roughened surface and nano-scale features are intervertebral body fusion devices intented for use for anterior cervical interbody firsion in skeletally mature 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 EIT Cellular Titanium Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. EIT Cellular Titanium Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. EIT Cellular Titanium® ALIF Cage: The EIT Cellular Titanium® ALIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition reguires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices. EIT Cellular Titanium® TLIF Cage: The EIT Cellular Titanium® TLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices. EIT Cellular Titanium® LLIF Cage: The EIT Cellular Titanium & LLF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two configuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confinued by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. ETT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. EIT Cellular Titanium® T/PLIF Cage: The EIT Cellular Titanium® T/PLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition regures the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondvlolisthesis at the involved level(s). These patients may have had a previous non-firsion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices.

The EIT Cellular Titanium® Technology platform is a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal/Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes. footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system). The EIT Cellular Titanium® Cages are made from Ti-6A1-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. The 3D Printed EIT Cellular Titanium® Cages have a microscopic roughened surface with micro and nano-scale features. The micro and nano features are on all surfaces of the cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.

The EIT Cellular Titanium® Lumbar Cages - T/PLIF in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

The EIT Cellular Titanium Lumbar Cages - T/PLIF are intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the lumbar spine (L2-S1). Multiple footprints, heights and lordotic angle cages are offered to accommodate varying patient anatomical and physiological requirements. The EIT Cellular Titanium Lumbar Cages - T/PLIF are made from Titanium-6Aluminum-4Vanadium ELI ASTM F3001 through an additive manufacturing process. The design contains solid structures and porous structures formed as a diamond mesh. The hollow geometry of the cages allows them to be packed with autogenous bone graft.

EIT Cellular Titanium® Lumbar Cage LLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.

The purpose of this Traditional 510(k) is to seek marketing clearance for the EIT Cellular Titanium® Lumbar Cage LLIF to be added to the EIT Spine line of lumbar interbody cages. The EIT Cellular Titanium® Lumbar Cage LLIF is used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using an LLIF (Lateral Lumbar Intervertebral Fusion) approach with autogenous bone graft and/or allogenic bone graft materials. The EIT Cellular Titanium® Lumbar Cage LLIF is intended to be used from L2-S1 in patients with DDD and up to Grade I spondylolisthesis or retrolisthesis at one or two contiguous levels. The device is intended to be used alongside supplemental spinal fixation. either applied anteriorly or posteriorly (e.g., using posterior pedicle screws). The EIT Cellular Titanium® Lumbar Cage LLIF is made from Ti-6AI-4V ELI (ASTM F3001) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous bone graft.

EIT Cellular Titanium® Cervical Cages: The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature 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 EIT Cellular Titanium® Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The EIT Cellular Titanium® Cervical Cages is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. EIT Cellular Titanium® PLIF Cages: The EIT Cellular Titanium® PLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices. EIT Cellular Titanium® TLIF Cages: The EIT Cellular Titanium® TLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices. EIT Cellular Titanium® ALIF Cages: The EIT Cellular Titanium® ALIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment with the devices.

The purpose of this 510(k) was to update the indications for use to include use at multiple levels (e.g., up to 4 levels) for the EIT Cellular Titanium® Cervical Cages as well as other miscellaneous labeling updates. The EIT Cellular Titanium® Cages are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine. The EIT Cellular Titanium® Cages differentiated in Lumbar cages (L2-S1) and Cervical Cages (C2-T1). The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g., using posterior pedicle screws, anterior plate system or anterior screw and rod system). The EIT Cellular Titanium® Cages are made from Ti-6AI-4V ELI ASTM F136 with an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft. Three different types of Lumbar Cages are included in the portfolio. Each cage type has the same intended use, but is designed for a different surgical approach; ALIF (Anterior Lumbar Intervertebral Fusion Cage), PLIF (Posterior Lumbar Intervertebral Fusion Cage) and TLIF (Transforaminal Lumbar Intervertebral Fusion Cage). One type of Cervical Cage, CIF (Cervical Intervertebral Fusion Cage) is included in the portfolio. Each cage type is supplied sterile and is available in a variety of heights, footprints and lordosis angles to accommodate patient anatomy.

EIT Cellular Titanium® Cervical Cage: The EIT Cellular Titanium® Cervical Cages are intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The EIT Cellular Titanium® Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. EIT Cellular Titanium® PLIF Cages: The ET Cellular Titanium® PLF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. EIT Cellular Titanium® TLIF Cages: The ETT Cellular Titanium® TLIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogemic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. EIT Cellular Titanium® ALIF Cages: The EIT Cellular Titanium® ALIF Cages in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenc pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

The EIT Cellular Titanium® Cages are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine. The EIT Cellular Titanium® Cages differentiated in Lumbar cages (L2-S1) and Cervical Cages (C2-T1). The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g., using posterior pedicle screws, anterior plate system or anterior screw and rod system). The EIT Cellular Titanium® Cages are made from Ti-6AI-4V ELI ASTM F136 with an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft. Three different types of Lumbar Cages are included in the portfolio. Each cage type has the same intended use, but is designed for a different surgical approach; ALIF (Anterior Lumbar Intervertebral Fusion Cage), PLIF (Posterior Lumbar Intervertebral Fusion Cage) and TLIF (Transforaminal Lumbar Intervertebral Fusion Cage). One type of Cervical Cage, CIF (Cervical Intervertebral Fusion Cage) is included in the portfolio. Each cage type is supplied sterile and is available in a variety of heights, footprints and lordosis angles to accommodate patient anatomy.