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 ACADIA™ System consists of superior and inferior facet joint implants made from cobalt chromium alloy with captive titanium and PEEK polyaxial locking components. The regions of the implant that contact bone have titanium plasma spray and hydroxyapatite coated ingrowth surfaces. The implants are compatible with the ACADIA™ Pedicle Screws, Top Nut, Cross-Link Clamps and Cross-bar (all titanium). The complete ACADIA™ Instrument System is required to successfully perform the procedure. The ACADIA™ implant is intended for use in patients with lateral, lateral recess and/or central canal stenosis at the L3 to S1 level who require a complete facetectomy and have failed six months of conservative treatment.

TGA Public Summary