510(k) · Cleared
ClearedRBknee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiobotics Aps · LLZ System, Image Processing, Radiological
Cleared on Aug 27, 2021 as substantially equivalent to K192109 (Ib Lab GmbH, 2019) after a 252-day review. Its family tree reaches back 8 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 27, 2021
- Review
- 252 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K942948 (1995). 11 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- 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 deviceK203696 RBkneeRadiobotics Aps · 2021
- Descendant · cites it directly · 1 of its ownK223621 DeepXrayAlpha Intelligence Manifolds, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253172 MediAI-OACrescom Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView 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) | K203696 | RBknee | Radiobotics Aps | 2021 | — |
| +1 | K223621 | DeepXray | Alpha Intelligence Manifolds, Inc. | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K192109 | KOALASummary page 5…nd Processing System (892.2050) Regulatory Class: Class II Product Codes: LLZ, JAK Classification Advisory Committee: Radiology Predicate Device: IB Lab GmbH, KOALA (K192109) Intended Use / Indications for Use RBknee is a radiological fully automated image processing software device of either compute… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223621 | DeepXray | 2023 | 1 |
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 26 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K223621 (Alpha Intelligence Manifolds, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K192109.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
RBknee is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren-Lawrence grading of standing…
Read the full statement (113 words)
RBknee is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren-Lawrence grading of standing, fixed-flexion radiographs of the knee.
It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203696: RBknee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203696
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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