# K261500: KBA3D (v2.4.0)

- Pathway: 510(k) (Traditional)
- Applicant: S.M.A.I.O
- Decided: Aug 17, 2026 after 103 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: 14 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)
- K223841: KBA3D, S.M.A.I.O (2023) Summary page 5.
- K213975: KEOPS Balance Analyzer 3D, S.M.A.I.O (2022) Summary page 5.

## Indications for use
The KBA3D v2.4.0 is intended for assisting healthcare professionals in viewing X-ray images, identifying spinal anatomical structures, simulating surgical correction strategies, and defining the geometry of patient-specific implants (such as rods) based on the surgeon's validated surgical plan. The device allows users to: * Manually identify anatomical structure on X-ray images » Perform spine-related measurements » Manually simulate surgical correction procedures * Design customized implant geometry Clinical judgment and experience are required to properly use the software.

Source page: https://510kreport.com/device/K261500
Methodology: https://510kreport.com/methodology