Device Dossier

Robotic surgical system software, navigation

Device Dossier for Robotic surgical system software, navigation (Robotic surgical system software, navigation, Class IIa, sponsor Stryker). ARTG record,…

Intended purpose

Intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. Indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy.

TGA Public Summary