Device Dossier

Athena Modular MIS System - Bone-screw internal spinal fixation system, non-sterile

Device Dossier for Athena Modular MIS System - Bone-screw internal spinal fixation system, non-sterile (Bone-screw internal spinal fixation system,…

Intended purpose

Spinal system intended for noncervical pedicle fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

TGA Public Summary