Device Dossier

Fixation device, internal, spine, construct

Device Dossier for Fixation device, internal, spine, construct (Fixation device, internal, spine, construct, Class IIb, sponsor Emergo). ARTG record,…

Intended purpose

The E.SPINE system is intended for posterior spinal surgery for the following indications: • Adult deformities (adult degenerative scoliosis, hyperkyphosis); • Pediatric deformities (neuromuscular scoliosis, congenital malformations, isthmic spondylolisthesis, Adolescent Idiopathic Scoliosis, syndromic scoliosis); • Degenerative pathologies (disc herniation, degenerative disc disease, stenosis, listhesis); • Trauma (lumbar and thoracic); • Tumors (primary or metastasis); • Revision surgery. It is worth noting that, certain implant components from E.SPINE system, as PEEK rods, are specifically excluded for use in pediatric patients. PEEK rods are preferred for arthrodesis on few levels. The E.SPINE TANIT iliosacral system is intended for posterior spinal surgery for the following indications: Severe paediatric neuro-muscular deformities (neuromuscular scoliosis).

TGA Public Summary