# K200589: MyPAO Planning Report

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Feb 19, 2021 after 350 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924630 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162559: Move Forward 3D Motion Simulation Service, Biomet, Inc. (2017) Summary page 4.

## Indications for use
Medacta MyPAO surgical planning report is 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.

Source page: https://510kreport.com/device/K200589
Methodology: https://510kreport.com/methodology