Device Dossier

Fixation device, internal, spine, construct

Device Dossier for Fixation device, internal, spine, construct (Fixation device, internal, spine, construct, Class IIb, sponsor Globus Medical). ARTG…

Intended purpose

The CORRIDOR™ Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from T1 to S1, and to stabilize Type II odontoid fractures. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. For Type II odontoid fixation, one or two screws are inserted anteriorly through the C2 vertebral body and into the odontoid process. The CORRIDOR™ Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma including spinal fractures and/or dislocations.

TGA Public Summary