Device Dossier

Orthopaedic intraoperative positioning pin, single-use

Device Dossier for Orthopaedic intraoperative positioning pin, single-use (Orthopaedic intraoperative positioning pin, single-use, Class IIa, sponsor…

Intended purpose

Surgically invasive guide pins, guide screws and navigation pins are used in orthopaedics as part of arthroplasty to fix templates or navigation antennas. They are inserted in a rotary motion in conjunction with a pin driver and/or with a surgical power unit or a hammer. The instruments are used on humans exclusively by surgeons and healthcare professionals in an operation room environment, provided the potential benefit outweighs the risk. Reprocessing is performed by reprocessing personnel in an appropriate reprocessing environment.

TGA Public Summary