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The aprevo® cervical ACDF interbody system includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with 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. The devices are to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The aprevo® cervical ACDF interbody system must be used with supplemental fixation (e.g., cervical plate or cervical posterior fixation).

The aprevo® cervical ACDF-X interbody system includes interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with 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. The devices are to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. When used with the screws that accompany the device, the aprevo® cervical ACDF-X interbody system is intended for use as a standalone system. Deformity procedures to correct coronal angulation or use of a hyperlordotic device (>20° lordosis) must include supplemental fixation (e.g., cervical plate or cervical posterior fixation).

The aprevo® cervical interbody system, which is comprised of the aprevo® cervical ACDF interbody system and the aprevo® cervical ACDF-X interbody system configurations, is designed to stabilize the cervical spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features 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® cervical interbody system interbody devices are additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and provided sterile, and the screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and provided sterile. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the interbody devices, are manufactured from stainless steel per ASTM A564 and provided sterile packaged for single patient use.

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