510(k) · Cleared
ClearedHipStudio Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Replasia BV · LLZ System, Image Processing, Radiological
Cleared on Sep 22, 2026 as substantially equivalent to K162559 (Biomet, Inc., 2017) after a 68-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Sep 22, 2026
- Review
- 68 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924630 (1993). 7 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK073468 MimicsMaterialise NV · 2008
- 2 generations backK132636 Dyonics Plan Hip Impingement Planning SystemSmith & Nephew, Inc. · 2013
- 1 generation backK162559 Move Forward 3D Motion Simulation ServiceBiomet, Inc. · 2017
- This deviceK262442 HipStudio AnalysisReplasia BV · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K073468 | Mimics | Materialise NV | 2008 | — |
| −2 | K132636 | Dyonics Plan Hip Impingement Planning System | Smith & Nephew, Inc. | 2013 | — |
| −1 | K162559 | Move Forward 3D Motion Simulation Service | Biomet, Inc. | 2017 | — |
| 0 (this device) | K262442 | HipStudio Analysis | Replasia BV | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K162559 | Move Forward 3D Motion Simulation ServiceSummary page 5…name "HipStudio Analysis" 3. Predicate and reference devices Predicate device: Move Forward 3D Motion Simulation Service, Zimmer Biomet [K162559]. Reference device: HipCheck, Stryker [K230045]. 4. Description of Device The HipStudio Simula… | 2017 |
| † | K230045 | HipCheck | 2023 |
| † | K073468 | Mimics | 2008 |
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 33 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K162559.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
HipStudio Simulation Service is an online image analysis service indicated for skeletally mature individuals that are suspected of suffering from symptomatic or asymptomatic hip conditions including but not limited to developmental dysplasia of the hip (DOH) and femoroacetabular impingement (FAI). It enables clinicians to obtain 3D motion simulation reports based on CT image data. The service can be used by uploading CT image data of hip joints. The…
Read the full statement (177 words)
HipStudio Simulation Service is an online image analysis service indicated for skeletally
mature individuals that are suspected of suffering from symptomatic or asymptomatic hip
conditions including but not limited to developmental dysplasia of the hip (DOH) and
femoroacetabular impingement (FAI).
It enables clinicians to obtain 3D motion simulation reports based on CT image data.
The service can be used by uploading CT image data of hip joints.
The image data is processed by Replasia to create 3D anatomy models. These 3D models
are then used to perform 3D motion simulations of the hip joint for different treatment
approaches and to calculate bone-to-bone contact points where impingement occurs.
The HipStudio Simulation Service also calculates several morphological shape parameters
for each of the 3D anatomy models.
The software generates a report as output. Clinicians do not interact with the image analysis
software directly. The image analysis software is only operated by Replasia operators who
have been specifically trained for this purpose. End users of the generated HipStudio
Simulation Service reports are trained medical professionals, including radiologists and
orthopedic surqeons.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262442: HipStudio Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262442
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026