510(k) · Cleared
ClearedOrtho AI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Ai, LLC · QIH Automated Radiological Image Processing Software
Cleared on Jan 2, 2025 as substantially equivalent to K192109 (Ib Lab GmbH, 2019) after a 204-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Jan 2, 2025
- Review
- 204 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K942948 (1995). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 7 generations backK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
- 6 generations backK090136 Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · Recalled
- 5 generations backK112109 The Kinegraph Vma Software, the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2011
- 4 generations backK130743 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0…Ortho Kinematics, Inc. · 2013
- 3 generations backK133875 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2…Ortho Kinematics, Inc. · 2014 · Recalled
- 2 generations backK172327 VMA™ System version 3.0Ortho Kinematics, Inc. · 2017
- 1 generation backK192109 KOALAIb Lab GmbH · 2019
- This deviceK241696 Ortho AIOrtho Ai, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| −7 | K022309 | Stryker Powered Wheeled Stretcher | Stryker Corp. | 2002 | 6 |
| −6 | K090136 | Steris Cmax XLT Surgical Table | STERIS Corporation | 2009 | 4 |
| −5 | K112109 | The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data… | Ortho Kinematics, Inc. | 2011 | — |
| −4 | K130743 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion… | Ortho Kinematics, Inc. | 2013 | — |
| −3 | K133875 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion… | Ortho Kinematics, Inc. | 2014 | 4 |
| −2 | K172327 | VMA™ System version 3.0 | Ortho Kinematics, Inc. | 2017 | — |
| −1 | K192109 | KOALA | Ib Lab GmbH | 2019 | — |
| 0 (this device) | K241696 | Ortho AI | Ortho Ai, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K192109 | KOALASummary page 5…assification: 892.2050 Medical image management and processing system Class: Class II Product Code: QIH Predicate Device: KOALA - K192109 Classification: 892.2050 Medical image management and processing system Class: Class II Pro… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K192109.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
Ortho Al is an image-processing software indicated to assist in making measurements for a total hip arthroplasty, total knee arthroplasty, and lumbar spine fusion surgery. It is intended to assist in the measurement of x-ray images by measuring lengths, angles and position of implants relative to the bone structures of interest provided, that the points of interest can be identified from radiology images. The device allows for overlaying of digital…
Read the full statement (143 words)
Ortho Al is an image-processing software indicated to assist in making measurements for a total hip arthroplasty, total knee arthroplasty, and lumbar spine fusion surgery.
It is intended to assist in the measurement of x-ray images by measuring lengths, angles and position of implants relative to the bone structures of interest provided, that the points of interest can be identified from radiology images.
The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. The software is not for primary image interpretation. The software is not for use on mobile phones.
Intended patient population: Adult patients >=22 years old, with appropriate imaging, undergoing primary hip replacement, primary knee replacement, and lumbar spine surgery.
Intended user population: orthopaedic surgeons who perform hip and knee replacement, and orthopaedic/neurosurgeons who perform lumbar spine surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241696: Ortho AI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241696
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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