# K223841: KBA3D

- Pathway: 510(k) (Traditional)
- Applicant: S.M.A.I.O
- Decided: May 30, 2023 after 159 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: 13 generations back to K896095 (1990). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213975: KEOPS Balance Analyzer 3D, S.M.A.I.O (2022) Summary page 4.
- K180091: UNiD Spine Analyzer, Medicrea International (2018) Summary page 4.
- K141669: Surgimap, Nemaris, Inc. (2014) Summary page 4.

## Most influential descendants
- K261500: KBA3D (v2.4.0) (2026), 0 descendants of its own

## Indications for use
The KBA3D v2.0.0 is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. Clinical judgment and experience are required to properly use the software. The patient population targeted with the use of the KBA3D v2.0.0 software includes patients with mature skeletons requiring imaging measurements and planning of surgical procedures. The Bendini Rod Bending algorithm is intended for patients older than 22 years old.

Source page: https://510kreport.com/device/K223841
Methodology: https://510kreport.com/methodology