# K223757: Bonelogic

- Pathway: 510(k) (Traditional)
- Applicant: Disior, Ltd.
- Decided: Dec 8, 2023 after 358 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: 6 generations back to K924630 (1993). 7 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203290: Bonelogic, Disior, Ltd. (2021) Summary page 5.

## Most influential descendants
- K240642: SMART Bun-Yo-Matic CT (2024), 2 descendants of its own
- K261641: Lower Limb AI (LLAI) (2026), 0 descendants of its own
- K250023: Smart PCFD (2025), 0 descendants of its own
- K240736: SMART Bun-Yo-Matic X-Ray (2024), 0 descendants of its own

## Indications for use
Bonelogic software is to be used by orthopaedic healthcare professionals for diagnosis and surgical planning in a hospital or clinic environment. Bonelogic software provides: • Semi-automatic segmentation with manual or assisted input of bony structure identification from CT imaging input, • Three-dimensional mathematical models of the anatomical structures of foot and ankle, • Measurement templates containing radiographic measures of foot and ankle, and tools for manually obtaining linear and angular measurements, • Surgical planning application for foot and ankle using three-dimensional models of the anatomical structures and radiographic measures. The three-dimensional models of the anatomical structures combined with the measurements can be used for the diagnosis of orthopaedic healthcare conditions. The surgical planning application containing the three-dimensional structural models combined with the measurements can be used for the planning of treatments and operations to correct orthopaedic healthcare conditions of foot and ankle.

Source page: https://510kreport.com/device/K223757
Methodology: https://510kreport.com/methodology