Device Dossier

Orthopaedic implantation application software

Device Dossier for Orthopaedic implantation application software (Orthopaedic implantation application software, Class IIa, sponsor Medacta). ARTG…

Intended purpose

Pre-operative planning software intended to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. The software is intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta's spinal fixation and fusion devices in skeletally mature and immature individuals. The software is designed to support the surgeon in producing a preoperative plan and making preliminary decisions on implant size and positioning. To properly use the software, clinical judgment and experience are required.

TGA Public Summary