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The aprevo® posterior/transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® posterior/transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach. The aprevo® posterior/transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six months of non-operative treatment. The aprevo® transforaminal lumbar interbody fusion device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). The device may be implanted via an open or minimally invasive approach.

The aprevo® posterior/transforaminal intervertebral body fusion device is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images. The aprevo® posterior/transforaminal lumbar interbody fusion device is additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and provided sterile. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the interbody device, are manufactured from stainless steel per ASTM A564 and provided sterile packaged for single use.

aprevo® anterior and lateral lumbar interbody fusion device: The aprevo® anterior and lateral lumbar interbody fusion devices are interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment. aprevo® anterior and lateral lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implanted via a variety of open or minimally invasive approaches. aprevo® anterior lumbar interbody fusion device with interfixation: The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplementation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implants may be implanted via a variety of open or minimally invasive approaches. ALIF-X implants are intended for standalone use at one or two levels of the spine when used with the screws that accompany the implant and with implants less than or equal to 20° of lordosis. At more than two levels or with implants greater than 20° of lordosis, ALIF-X is intended to be used with the screws that accompany each implant and with supplemental fixation. When used at more than one level in patients with degenerative scoliosis and/or sagittal deformity, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

aprevo® anterior and lateral lumbar interbody fusion device: The aprevo® anterior and lateral lumbar interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images. The aprevo® anterior and lateral lumbar interbody fusion devices are additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and are provided sterile. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the interbody devices, are manufactured from stainless steel and provided sterile packaged for single use. aprevo® anterior lumbar interbody fusion device with interfixation: The aprevo® anterior lumbar interbody fusion device with interfixation is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features to allow the surgeon to tailor the procedure to the individual needs of the patient and include an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images. The aprevo® anterior lumbar interbody fusion device with interfixation is additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and is provided sterile. The device includes screws that are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and are offered in a range of lengths. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the device, are manufactured from stainless steel and provided sterile packaged for single use.

The aprevo® Digital Planning software is intended to be used by trained, medically knowledgeable design personnel to generate surgical plans for skeletally mature patients. The device processes a 3D spine model in conjunction with inputs from healthcare professionals to produce 3D models of spinal corrections and anatomical measurements.

The aprevo® Digital Planning, is a rules-based, semi-automated surgical planning software that, based on surgeon input, measures the 3D spine model and results in a spinal correction plan. The outputs consist of a surgical plan and 3D spinal correction assets, which are then reviewed by the surgeon. The device is operated by trained, medically knowledgeable Carlsmed design personnel.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implants may be implanted via a variety of open or minimally invasive approaches. ALIF-X implants are intended for standalone use at one or two levels of the spine when used with the screws that accompany the implant and with implants less than or equal to 20 degrees of lordosis. At more than two levels or with implants greater than 20 degrees of lordosis, ALIF-X is intended to be used with the screws that accompany each implant and with supplemental fixation. When used at more than one level in patients with degenerative scoliosis and/or sagittal deformity, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The aprevo® anterior lumbar interbody fusion device with interfixation is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features to allow the surgeon to tailor the procedure to the individual needs of the patient and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001, while the screws are machined from material per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instrument are provided as single use, sterile-packed product to the end user. The purpose of this 510(k) is to modify the indications for use of the subject device to include standalone indications.

The aprevo® Cervical ACDF Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kvphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF Interbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20 lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation. The aprevo® Cervical ACDF-X Interbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X Interbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal anqulation or any use of hyperlordotic correction (>20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.

The aprevo® Cervical ACDF System, which includes the aprevo® Cervical ACDF Interbody, aprevo® Cervical ACDF-X Interbody, and the aprevo® Cervical ACDF-X (no cam) Interbody are designed to stabilize the cervical spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient-specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture for the packing of bone graft. The aprevo® Cervical ACDF System interbodies are additively manufactured from Ti-6AI-4V ELI titanium alloy per F3001, while the screw are machined from Ti alloy per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and the instrument are provided to the end-user as single use, sterile-packed products.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an OD! >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with mvelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.

The aprevo® anterior lumbar interbody fusion device with fixation (ALIF-X is) designed to stabilize the lumbar spinal column and promote fusion. The personalized aprevo® interbodies incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture intended for the packing of bone graft. The aprevo® ALIF-X device is accompanied by three screws designed to be used to provide fixation. The aprevo® ALIF-X interbodies are additively manufactured from Ti-6A1-4V ELI titanium alloy per ASTM F3001, while the screws are machined from material per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instrument are provided as single use, sterile-packed product to the end user.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment, aprevo® lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation. aprevo anterior and lateral lumbar interbody fusion devices (ALIF and LLIF): The aprevo® anterior and lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplementation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI>40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non- operative treatment. aprevo anterior and lateral lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implanted via a variety of open or minimally invasive approaches. aprevo® transforaminal lumbar interbody fusion devices (TLIF): The aprevo® transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® transforaminal lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implanted via a variety of open or minimally invasive approaches.

The aprevo® Intervertebral Body Fusion Devices include ALIF-X, ALIF, LLIF, TLIF-O, and TLIF-C interbodies. The aprevo® interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient.

aprevo® ALIF and LLIF: The aprevo® anterior and lateral lumbar interbody fusion devices are interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® anterior and lateral lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches. aprevo® TLIF: The aprevo® transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels, of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® transforaminal lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches. aprevo® ALIF-X: The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.

The aprevo® anterior, lateral and transforaminal lumbar interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001 and are provided sterile. The aprevo® anterior lumbar interbody fusion device with interfixation, (ALIF-X), is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from Titanium Alloy (Ti-6Al-4V) per ASTM F3001 and ASTM F136. The aprevo® ALIF-X device has a cavity intended for the packing of bone graft.

The aprevo® TLIF-C Articulating System is interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® TLIF-C Articulating System is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® TLIF-C Articulating System is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® TLIF-C Articulating System devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® TLIF-C Articulating System devices are designed to stabilize the lumbar spinal column and promote fusion. The personalized aprevo® interbodies incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture intended for the packing of bone graft. The aprevo® TLIF-C Articulating interbodies are additively manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instrument are provided as single use, sterile-packed product to the end user.