# K221432: Customize

- Pathway: 510(k) (Traditional)
- Applicant: 3D-Side S.A.
- Decided: Aug 3, 2022 after 78 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213779: Customize, 3D-Side S.A. (2022) Summary page 4.

## Indications for use
Customize for ankle arthroplasty is intended to be used as a software interface to assist in: - Visualization, modification, validation of the planning of total ankle arthroplasty - Communication of treatment options - Segmentation of CT-scan data - 3D CAD models generation - use x-ray scan information to enhance the planning of ankle arthroplasty - Managing timeline and cases Customize is not intended to be used for - Spine surgeries - Implant and instrument design Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.

Source page: https://510kreport.com/device/K221432
Methodology: https://510kreport.com/methodology