# K220706: MyPAO Guides

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: May 30, 2023 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: 1 generation back to K190044 (2019). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190044: VSP Orthopedics System, 3D Systems, Inc. (2019) Summary page 4.

## Most influential descendants
- K242603: MyPAO SA guides (2025), 0 descendants of its own

## Indications for use
MyPAO 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 guides are intended for single use only.

Source page: https://510kreport.com/device/K220706
Methodology: https://510kreport.com/methodology