Device Dossier

Bone-screw internal spinal fixation system, sterile

Device Dossier for Bone-screw internal spinal fixation system, sterile (Bone-screw internal spinal fixation system, sterile, Class IIb, sponsor Emergo).…

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). The NEMOST growing domino is intended for the following indications: • idiopathic scoliosis; • congenital scoliosis; • neuromuscular scoliosis; • syndromic scoliosis. This surgical treatment should only be considered in the case of progressive spinal deformation, which does not respond little or no to orthopaedic treatments, in a growing child (RISSER 0) and with first surgical intention.

TGA Public Summary