ASTRA Spine System - Bone-screw internal spinal fixation system, non-sterile

Intended purpose

This system is intended to provide stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities of the spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudo-arthrosis). This system is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained. This system is also a sacral/iliac screw fixation system indicated for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, and previous failed fusion. When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, this system is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients with autograft and/or allograft, the system implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. When used without OSTEOPAL® plus PMMA Bone Cement or equivalent, this system’s fenestrated Screws are intended for posterior, non-cervical pedicle fixation as an adjunct to fusion for the following indications: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion. When used in conjunction with OSTEOPAL® plus PMMA Bone Cement or equivalent, this system’s fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.