Device Dossier

Stereotactic surgery system, orthopaedic

Device Dossier for Stereotactic surgery system, orthopaedic (Stereotactic surgery system, orthopaedic, Class IIa, sponsor Navbit). ARTG record, intended…

Intended purpose

A computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. Facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population is that of a patient undergoing a Hip Arthroplasty surgical procedure in an approach suitable to the System (e.g., Posterior Hip Arthroplasty).

TGA Public Summary