Device Dossier

Spinal cage

Device Dossier for Spinal cage (Spinal cage, Class IIb, sponsor Additive Surgical). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

The Additive Surgical PorOssity ACIF device is intended to restore intervertebral height and to facilitate intervertebral body fusion in the cervical spine column (C2-T1). The PorOssity ACIF Cage is designed to be applied with an Anterior Cervical approach only (ACIF). ACIF is indicated for use in skeletally mature patients with; • degenerative disc diseases, • spinal stenosis, • revision surgery for failed disc surgery, • progressive degenerative discopathies, • foraminal stenosis or nerve compression, • pseudarthrosis, or • instability of motion segments. As a complementary device, it should NOT be used as a stand-alone but must be used in combination with other spinal fixation systems (e.g. plates and screws). The device must always be within the limits of the vertebral cortices and on skeletally mature patients.

TGA Public Summary