# K242603: MyPAO SA guides

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Nov 19, 2025 after 446 days
- Product code: PBF (Orthopaedic Surgical Planning And Instrument Guides)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K190044 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220706: MyPAO Guides, Medacta International S.A. (2023) Summary page 5.

## Indications for use
MyPAO SA patient-specific guides are 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. MyPAO SA guides are intended for single use only.

Source page: https://510kreport.com/device/K242603
Methodology: https://510kreport.com/methodology