510(k) · Cleared
ClearedVMA™ System version 3.0
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 Aug 25, 2017 as substantially equivalent to K133875 (Ortho Kinematics, Inc., 2014) after a 24-day review. Its family tree reaches back 6 generations to 1995. 7 later devices descend from it.
- Decided
- Aug 25, 2017
- Review
- 24 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K942948 (1995). 9 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 5 generations backK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
- 4 generations backK090136 Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · Recalled
- 3 generations backK112109 The Kinegraph Vma Software, the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2011
- 2 generations backK130743 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0…Ortho Kinematics, Inc. · 2013
- 1 generation backK133875 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2…Ortho Kinematics, Inc. · 2014 · Recalled
- This deviceK172327 VMA™ System version 3.0Ortho Kinematics, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK192109 KOALAIb Lab GmbH · 2019
- Descendant · 2 generations on · 2 of its ownK203696 RBkneeRadiobotics Aps · 2021
- Descendant · 2 generations on · 1 of its ownK223621 DeepXrayAlpha Intelligence Manifolds, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK223646 IB Lab LAMAIb Lab GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK253172 MediAI-OACrescom Co., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K192109KOALAIb Lab GmbH · 2019 · cites it directly6descendants
- K203696RBkneeRadiobotics Aps · 2021 · 2 generations on2descendants
- K223621DeepXrayAlpha Intelligence Manifolds, Inc. · 2023 · 2 generations on1descendant
- K223646IB Lab LAMAIb Lab GmbH · 2023 · 2 generations on1descendant
- K253172MediAI-OACrescom Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| −5 | K022309 | Stryker Powered Wheeled Stretcher | Stryker Corp. | 2002 | 6 |
| −4 | K090136 | Steris Cmax XLT Surgical Table | STERIS Corporation | 2009 | 4 |
| −3 | K112109 | The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data… | Ortho Kinematics, Inc. | 2011 | — |
| −2 | K130743 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion… | Ortho Kinematics, Inc. | 2013 | — |
| −1 | K133875 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion… | Ortho Kinematics, Inc. | 2014 | 4 |
| 0 (this device) | K172327 | VMA™ System version 3.0 | Ortho Kinematics, Inc. | 2017 | — |
| +1 | K192109 | KOALA | Ib Lab GmbH | 2019 | — |
| +2 | K203696 | RBknee | Radiobotics Aps | 2021 | — |
| +2 | K223621 | DeepXray | Alpha Intelligence Manifolds, Inc. | 2023 | — |
| +2 | K223646 | IB Lab LAMA | Ib Lab GmbH | 2023 | — |
| +3 | K253172 | MediAI-OA | Crescom Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133875 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion…Summary page 4…and communications system (21 C.F.R. 892.2050) Regulatory Class: Class II Product Code: LLZ Predicate Device Ortho Kinematics, Inc.’s VMA System, version 2.2 (K133875) Device Description The subject device consists of the following components and accessories: VMA™ software (for d… | 2014 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192109 | KOALA | 2019 | 6 |
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 22 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K192109 (Ib Lab GmbH, 2019) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 VMA software is a quantitative imaging software application intended to be used to process any diagnostic imaging modality except mammography from digital image files in DICOM format. It is designed for physicians and clinical professionals who are interested in the analysis of alignment and motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar, thoracic…
Read the full statement (163 words)
The VMA software is a quantitative imaging software application intended to be used to process any diagnostic imaging modality except mammography from digital image files in DICOM format. It is designed for physicians and clinical professionals who are interested in the analysis of alignment and motion in medical images, particularly in musculoskeletal images of the spine. VMA software permits users to review static and dynamic digital lumbar, thoracic, and cervical spine images. In the case of fluoroscopic images, these are 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. VMA software also facilitates quantitative assessment of vertebral alignment and motion in digital medical images. Information about the alignment and 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/K172327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172327: VMA™ System version 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172327
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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