# K133875: The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion Normalizer Patient Handling and Data

- Pathway: 510(k) (Special)
- Applicant: Ortho Kinematics, Inc.
- Decided: Jan 17, 2014 after 28 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K942948 (1995). 8 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130743: The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion Normalizer Patient Handling and Data Coll, Ortho Kinematics, Inc. (2013) Summary page 1.

## Most influential descendants
- K172327: VMA™ System version 3.0 (2017), 7 descendants of its own
- K192109: KOALA (2019), 6 descendants of its own
- K203696: RBknee (2021), 2 descendants of its own
- K223621: DeepXray (2023), 1 descendant of its own
- K223646: IB Lab LAMA (2023), 1 descendant of its own

## Recalls of this device
- May 23, 2018 · Class II · Z-2889-2018: This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.
- Mar 2, 2017 · Class II · Z-2891-2018: Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings
- Jan 11, 2017 · Class II · Z-2882-2018: Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred d
- Aug 12, 2016 · Class II · Z-2890-2018: Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.

## Indications for use
The KineGraph VMATM software is a quantitative imaging software application intended to be used to process digital image files. It is designed for physicians and clinical professionals who are interested in the analysis of motion in medical images, particularly in musculoskeletal images of the spine. KineGraph VMATM software permits users to review static and dynamic digital lumbar and cervical spine images acquired with the assistance of the Motion Normalizer patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar and cervical bending and data collection during imaging. KineGraph VMATM software also facilitates quantitative assessment of vertebral motion in digital medical images. Information about the motion of selected objects, such as bone structures, can be generated and presented in the form of a 'motion analysis' report containing graphics, charts, and text.

Source page: https://510kreport.com/device/K133875
Methodology: https://510kreport.com/methodology