Polymeric spinal fusion cage, non-sterile

Intended purpose

Transcend NanoTec Cervical Interbody System and Transcend NanoTec SPS System: The Transcend Cervical PEEK Interbody System/Transcend SPS Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for use in skeletally mature patients with 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 Transcend NanoTec Cervical Interbody System/Transcend NanoTec SPS Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft composed of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler for use in intervertebral body fusion. Transcend PEEK Interbody System and Transcend NanoTec Interbody System: The Transcend PEEK Interbody System and Transcend NanoTec Interbody System with advanced NanoTec surface treatment are indicated for spinal fusion procedures from Tl to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Transcend PEEK Interbody System and Transcend NanoTec Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Transcend PEEK Interbody System and Transcend NanoTec Interbody System are intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler for use in intervertebral body fusion, and supplemental fixation systems for use in the thoracic and lumbar spine. AMP Anti-Migration Plate may be used with Transcend LIF interbody spacers to provide integrated fixation. Transcend LIF spacers with >20° lordosis must be used with AMP Anti Migration Plate in addition to supplemental fixation. Transcend ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.