Device Dossier
Orthopaedic implantation application software
Device Dossier for Orthopaedic implantation application software (Orthopaedic implantation application software, Class IIa, sponsor Medacta). ARTG…
- GMDN category: Orthopaedic implantation application software
Intended purpose
Software intended to provide users with patient’s pre-operative information and an estimation of the post-operative parameters after the realignment of the acetabulum following the osteotomy. It is intended to be used for the pre-operative planning phase of Peri-Acetabular Osteotomy surgeries and it consists of a report in .pdf format elaborated on the basis of Patient’s Anatomical Data derived from the CT scan of the patient. The planning report is generated through a validated internal Medacta Manufacturing software and with a highly specialized engineering manual landmark selection. The Medical Device, in accordance with a written prescription of the Surgeon, is intended for the sole use of the specific patient for which the case is created. Medacta MyPAO surgical planning is intended to be used on a skeletally mature population for which a PAO surgery is required.