510(k) · Cleared
ClearedThe Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data Collection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Kinematics, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 22, 2011 as substantially equivalent to K022585 (Medical Metrics, Inc., 2002) and 1 other predicate after a 153-day review. Its family tree reaches back 3 generations to 1995. 10 later devices descend from it.
- Decided
- Dec 22, 2011
- Review
- 153 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K942948 (1995). 6 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 2 generations backK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
- 1 generation backK090136 Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · Recalled
- This deviceK112109 The Kinegraph Vma Software, the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2011
- Descendant · cites it directly · 9 of its ownK130743 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0…Ortho Kinematics, Inc. · 2013
- Descendant · 2 generations on · 8 of its ownK133875 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2…Ortho Kinematics, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 7 of its ownK172327 VMA™ System version 3.0Ortho Kinematics, Inc. · 2017
- Descendant · 4 generations on · 6 of its ownK192109 KOALAIb Lab GmbH · 2019
- Descendant · 5 generations on · 2 of its ownK203696 RBkneeRadiobotics Aps · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K130743The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion…Ortho Kinematics, Inc. · 2013 · cites it directly9descendants
- K133875The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion…Ortho Kinematics, Inc. · 2014 · 2 generations on8descendants
- K172327VMA™ System version 3.0Ortho Kinematics, Inc. · 2017 · 3 generations on7descendants
- K192109KOALAIb Lab GmbH · 2019 · 4 generations on6descendants
- K203696RBkneeRadiobotics Aps · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| −2 | K022309 | Stryker Powered Wheeled Stretcher | Stryker Corp. | 2002 | 6 |
| −1 | K090136 | Steris Cmax XLT Surgical Table | STERIS Corporation | 2009 | 4 |
| 0 (this device) | K112109 | The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data… | Ortho Kinematics, Inc. | 2011 | — |
| +1 | K130743 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion… | Ortho Kinematics, Inc. | 2013 | — |
| +2 | K133875 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion… | Ortho Kinematics, Inc. | 2014 | 4 |
| +3 | K172327 | VMA™ System version 3.0 | Ortho Kinematics, Inc. | 2017 | — |
| +4 | K192109 | KOALA | Ib Lab GmbH | 2019 | — |
| +5 | K203696 | RBknee | Radiobotics Aps | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022585 | Kimax QmaSummary page 1…data collection device PREDICATE DEVICE Medical Metrics, Inc.'s KIMAX QMA Radiological Image Processing System (K0225 85) Villa Sistemi Medicali, spa's Apollo (KOS50190) Steris Corporation's Steris 5085 SRT (K090 136) INTENDE… | 2002 |
| Kept off the family tree | K0850190 | Apollo Number could not be read | |
| * | K090136 | Steris Cmax XLT Surgical TableSummary page 1…Radiological Image Processing System (K0225 85) Villa Sistemi Medicali, spa's Apollo (KOS50190) Steris Corporation's Steris 5085 SRT (K090 136) INTENDED USE / INDICATIONS FOR USE The KINEGRAPH VMATM software is a quantitative imaging software application… | 2009 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130743 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion… | 2013 | 9 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K130743 (Ortho Kinematics, Inc., 2013) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K022585.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (137 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112109: The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data Collection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112109
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026