# K221725: Advanced MyHip Planner

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jan 20, 2023 after 220 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: 11 generations back to K896095 (1990). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200350: MyHip Planner & Verifier, Medacta International S.A. (2020) Summary page 4.

## Indications for use
The MyHip Planner software is intended for image processing and preoperative planning of acetabular cup and femoral stem positioning for Total Hip Arthroplasty (THA). The user is assisted in producing a preoperative plan, making decisions based on the leg offsets, the patient's potential impingement and, optionally, the spino-pelvic interaction. Through the software, the user can request 3D Printed Patient Specific Bone Models not intended for diagnostic use, but only intended for a physical representation of the 3D anatomical models visualized in the software. The 3D Printed Patient Specific Bone Models are provided non-sterile.

Source page: https://510kreport.com/device/K221725
Methodology: https://510kreport.com/methodology