Device Dossier

Spinal cage

Device Dossier for Spinal cage (Spinal cage, Class IIb, sponsor 3DMorphic). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

A system including a device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). The interbody fusion cage is intended to maintain the height between vertebral bodies adjacent to the device and support loading during fusion and can be of several different geometric forms. The interbody fusion cage is implanted between the bones of the spine providing mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. This process helps to relieve pressure on pinched nerves and prevents vertebral slipping. Bone graft is typically used to help with osseointegration. The interbody fusion device may be made of metal, polymer, or other artificial or biological materials, or it may be a combination of these. Fixation screws and devices associated with implantation are included with the device. Included devices: off-the-shelf interbody fusion cage with integral fixation, bone fixation screws, integral screw locking cap, biomodel, custom-made interbody fusion cage with integral fixation, Virtual Surgery Plan. The integral screw fixation combined with custom fit is intended to give immediate and long-term stability to the operative level, which is intended to aid the fusion process.

TGA Public Summary