# K203290: Bonelogic

- Pathway: 510(k) (Traditional)
- Applicant: Disior, Ltd.
- Decided: Feb 5, 2021 after 88 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: 5 generations back to K924630 (1993). 6 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K183105: Mimics Medical, Materialise NV (2019) Summary page 4.

## Most influential descendants
- K223757: Bonelogic (2023), 4 descendants of its own
- 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 intended to be used by specialized medical practitioners to assist in the characterization of human anatomy with 3D visualization and specific measurements. The medical image modalities intended to be used in the software are computed tomography (CT) images, cone beam computed tomography (CBCT) images and weight-bearing cone beam CT (WBCT) images. The intended patient population is adults over 16 years of age. Bonelogic software contains the measurement template with a set of distance and angular measures. The measurements can be used for diagnostic purposes. The three dimensional (3D) models are displayed and can be manipulated in the software. Together, the information from the measurements and the 3D visualization can be used for treatment planning in the field of orthopedics (foot and ankle, and hand and wrist). The 3D models can be outputted from the software for traditional or additive manufacturing. The physical models generated based on the 3D digital models are not intended for diagnostic use.

Source page: https://510kreport.com/device/K203290
Methodology: https://510kreport.com/methodology