Device Dossier

Polymeric spinal fusion cage, non-sterile

Device Dossier for Polymeric spinal fusion cage, non-sterile (Polymeric spinal interbody fusion cage, Class IIb, sponsor Kynesis). ARTG record, intended…

Intended purpose

The cage is indicated for lumbar and lumbosacral pathologies indicated for segmental arthrodesis in skeletally mature patients, including: degenerative discopathy; primary surgery for advanced discopathies or extensive destabilisation decompressions; revision surgery for failed disc and surgery (i.e. recurrent disc herniation, post-operative instability); lumbar pseudarthrosis, certain lumbar stenosis; degenerative and isthmic spondylolisthesis with grade I residual displacement after reduction.

TGA Public Summary