# K250023: Smart PCFD

- Pathway: 510(k) (Traditional)
- Applicant: Disior, Ltd.
- Decided: Sep 29, 2025 after 269 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: 8 generations back to K924630 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240642: SMART Bun-Yo-Matic CT, Disior, Ltd. (2024) Summary page 6.
- K223757: Bonelogic, Disior, Ltd. (2023) Summary page 7.

## Indications for use
SMART PCFD software includes AI-powered algorithms and is intended to be used to support orthopedic healthcare professionals in the diagnosis and surgical planning of Progressive Collapsing Foot Deformity (PCFD) in a hospital or clinic environment. The medical image modality intended to be used in the software is weight-bearing CT (WBCT). SMART PCFD software provides for the user: * Visualization report of the three-dimensional (3D) mathematical models and measurements of the anatomical structures of foot and ankle and three-dimensional models of orthopedic fixation devices, * Measurement templates containing radiographic measures of foot and ankle, and * Surgical planning application for visualization of foot and ankle anatomical three-dimensional structures, radiographic measures, and surgical instrument parameters supporting the following common flatfoot procedures: Medial Displacement Calcaneal Osteotomy (MDCO), Lateral Column Lengthening (LCL), and Cotton Osteotomy (CO). The visualization report containing the measurements is intended to be used to support orthopedic healthcare professionals in the diagnosis of PCFD. The surgical planning application contains the visualizations of the three-dimensional structural models, orthopedic fixation device models and surgical instrument parameters combined with the measurements is intended to be used to support orthopedic healthcare professionals in surgical planning of PCFD.

Source page: https://510kreport.com/device/K250023
Methodology: https://510kreport.com/methodology