# K112109: The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Kinematics, Inc.
- Decided: Dec 22, 2011 after 153 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: 3 generations back to K942948 (1995). 6 ancestors in all.
10 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)
- K022585: Kimax Qma, Medical Metrics, Inc. (2002) Summary page 1.
- K090136: Steris Cmax XLT Surgical Table, STERIS Corporation (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K0850190: Apollo. Number could not be read

## Most influential descendants
- K130743: The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion Normalizer Patient Handling and Data Coll (2013), 9 descendants of its own
- K133875: The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion Normalizer Patient Handling and Data (2014), 8 descendants of its own
- 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

## 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 spine images acquired with the assistance of the MOTION NORMALIZERTM patient handling and data collection device, which is designed for use by imaging technicians and intended to assist with patient lumbar 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/K112109
Methodology: https://510kreport.com/methodology