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X-PAC® TLIF Expandable Posterior Cage System 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 intended to be used with autograft and/or allograft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. X-PAC® TLIF Expandable Posterior Cage System 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. X-PAC® LLIF Expandable Lateral Cage System 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 intended to be used with autograft and/or allograft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. X-PAC® LLIF Expandable Lateral Cage System 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 X-PAC® TLIF Expandable Posterior Cage System and X-PAC® LLIF Expandable Lateral Cage System are lumbar interbody fusion systems comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via a transforaminal or lateral approach. The device is available in various sizes and footprints to accommodate varying anatomy and is designed to allow for intraoperative adjustment in the height of the cage. Surfaces of the upper plate and bottom housing that contact the vertebral endplates are "toothed" to provide stability within the intervertebral space. The outer surface teeth are designed to resist expulsion in all directions. The fenestrated cage contains openings to enhance bony ingrowth and has a bulleted nose for easier entry into the disc space. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. The X-PAC® TLIF Expandable Posterior Cage System and X-PAC® LLIF Expandable Lateral Cage System implants are single-use, provided non-sterile, and are intended to be steam sterilized before use. The surgical instruments are designed to facilitate precise placement of the device within the intervertebral disc body, and are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.

The Expanding Innovations X-Pac Expandable LLIF Cage System 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 radies. These DDD patients may also have up to Grade 1 spondylolisthesis 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. The X-Pac Expandable LLIF Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Expanding Innovations X-Pac Expandable LLIF Cage System is a lumbar interbody fusion system comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via the lateral approach. The device is available in various sizes and footprints to accommodate varying anatomy, and is designed to allow for intraoperative adjustment. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. The Expanding Innovations X-Pac Expandable LLIF Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The surgical instruments are reusable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use.

The Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

The X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via the transforaminal approach. The device is available in different sizes and footprints, to accommodate varying patient anatomy, and is designed to allow for intraoperative adjustment in both the parallel and lordotic configurations. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136 and ASTM F1295. The Expanding Innovations X-Pac Expandable Lumbar Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The surgical instruments are re-usable, provided non-sterile, and are intended to be cleaned and steam sterilized before each use. Additional cage sizes are the subject of this Special 510(k).