Device Category Dossier

Custom-made anatomy model/surgical guide kit

Device Category Dossier for Custom-made anatomy model/surgical guide kit. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Patient-matched surgical guides and anatomical models are manufactured using 3-D printing and CAD/CAM techniques to match patient-specific anatomy and assist with surgical instrument guidance, implant component orientation, and anatomical alignment during operative procedures. These devices are used across maxillofacial surgery, mandibular and orthognathic procedures, orthopaedic surgery, and dental implant placement to facilitate intraoperative execution of preoperative surgical plans.