Device Dossier

Custom-made orthopaedic surgical guide, non-sterile

Device Dossier for Custom-made orthopaedic surgical guide, non-sterile (Custom-made orthopaedic surgical guide, non-sterile, Class IIa, sponsor Medacta).…

Intended purpose

Devices intended to be used as anatomical guides. The guides are specifically designed based on the CT images of the patient (i.e., pelvis, proximal femur, distal femur). The guides are intended to assist the surgeon in the positioning of the acetabular fragment during periacetabular osteotomies to treat patients who require to undergo periacetabular osteotomy. The guides are intended for single use only.

TGA Public Summary