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The ASTRAEUS anterior lumbar interbody fusion device is a member of interbody fusion devices intended for interbody fusion procedures (arthrodesis) 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous bone graft. GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ASTRAEUS ALIF cage is to be implanted via an anterior approach. The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The PROMETHEUS PLIF cage is to be implanted via a posterior approach. The THEMIS Transforaminal posterior lumbar is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with disc disease (DDD) at one or two contiquous 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. GAIA devices, including the THEMS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.

The GAIA Lumbar Interbody Fusion Device (LIFD) Family consists of the ASTRAEUS ALIF, the PROMETHEUS PLIF, and the THEMIS TPLIF. The ASTRAEUS anterior lumbar interbody fusion (ALIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The ASTRAEUS ALIF devices are to be implanted via an anterior approach. The PROMETHEUS posterior lumbar interbody fusion (PLIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The PROMETHEUS PLIF devices are to be implanted via a posterior approach. The THEMIS transforaminal posterior lumbar interbody fusion (TPLIF) implants are interbody fusion devices intended for use an aid in spinal fixation and provided structural stability in skeletally mature patients. THE THEMIS TPLIF devices are to be implanted via a transforaminal or posterior approach. The GAIA Lumbar Interbody Fusion Device (LIFD) Family implants are manufactured additively from titanium alloy (Ti-6Al-4V) per ASTM F3001 and are offered in a variety of standard sizes (width, length, height, lordotic angle) designed to adapt to many different patient anatomy. Each interbody device has an axial graft window to allow bone grafting material of autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to be placed inside the interbody. Various interbody window lattices are provided to adapt to various bone graft placement methods. High friction surfaces with protrusions on superior and inferior of the interbody fusion device grip the end plates of adjacent vertebrae to resist expulsion or other unintended migration of the implants provide an alternative to autogenous bone graft blocks and assist to reduce complications related to bone graft.