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The Acro Composites Interbody System is intended for interbody fusion. The devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and are to be used with supplemental fixation cleared for the implanted level. The Acro Composites cervical devices are intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The cervical devices are indicated to treat 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 hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. The Acro Composites lumbar devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The lumbar devices are indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The hyperlordotic implants (≥ 20°) should be used with anterior supplemental fixation.

The Acro Composites Interbody System includes interbody fusion devices for cervical and lumbar implantation manufactured from AcroPek – a carbon fiber reinforced PEKEKK polymer (CFRP) material. The implants are designed as a solid frame to provide surgical stabilization of the spine. Each interbody incorporates a central cavity that can be packed bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. The implants are sold sterile.