510(k) · Cleared
ClearedMimics Medical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · LLZ System, Image Processing, Radiological
Cleared on Mar 27, 2019 as substantially equivalent to K073468 (Materialise NV, 2008) after a 139-day review. Its family tree reaches back 4 generations to 1993. 34 later devices descend from it.
- Decided
- Mar 27, 2019
- Review
- 139 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924630 (1993). 5 ancestors in all, the oldest K924810 (1993). 34 later devices descend from it, 17 citing it directly.
- Root · 4 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 3 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 2 generations backK033849 Simplant SystemMaterialise NV · 2004
- 1 generation backK073468 MimicsMaterialise NV · 2008
- This deviceK183105 Mimics MedicalMaterialise NV · 2019
- Descendant · cites it directly · 5 of its ownK203290 BonelogicDisior, Ltd. · 2021
- Descendant · 2 generations on · 4 of its ownK223757 BonelogicDisior, Ltd. · 2023
- Descendant · cites it directly · 3 of its ownK234009 Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2024
- Descendant · cites it directly · 3 of its ownK212420 Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements…Brainlab AG · 2021
- Descendant · 3 generations on · 2 of its ownK240642 SMART Bun-Yo-Matic CTDisior, Ltd. · 2024
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K203290BonelogicDisior, Ltd. · 2021 · cites it directly5descendants
- K223757BonelogicDisior, Ltd. · 2023 · 2 generations on4descendants
- K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical · 2024 · cites it directly3descendants
- K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG · 2021 · cites it directly3descendants
- K240642SMART Bun-Yo-Matic CTDisior, Ltd. · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −3 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −2 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −1 | K073468 | Mimics | Materialise NV | 2008 | — |
| 0 (this device) | K183105 | Mimics Medical | Materialise NV | 2019 | — |
| +1 | K203290 | Bonelogic | Disior, Ltd. | 2021 | — |
| +2 | K223757 | Bonelogic | Disior, Ltd. | 2023 | — |
| +1 | K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2024 | — |
| +1 | K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements… | Brainlab AG | 2021 | — |
| +3 | K240642 | SMART Bun-Yo-Matic CT | Disior, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 9 | 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.
What descends from it? (34)
See all 3417 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203290 | Bonelogic | 2021 | 5 |
| K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | 2024 | 3 |
| K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking… | 2021 | 3 |
| K190874 | Materialise Mimics Enlight | 2019 | 2 |
| K231955 | aprevo® Digital Segmentation | 2023 | 1 |
| K222987 | Akunah REFLECT | 2023 | 1 |
| K213684 | SurgiCase Viewer | 2022 | 1 |
| K210726 | ImmersiveTouch | 2021 | 1 |
| K254214 | Ooopds | 2026 | 0 |
| K251964 | Mimics Thoracic Planner | 2026 | 0 |
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 2 companies; a new generation was cleared every 7.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K203290 (Disior, Ltd., 2021) has gone furthest, with 5 descendants of its own.
- 8 other devices also cite its predicate K073468.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Mimics Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Mimics Medical is also intended for measuring and treatment planning.
The Mimics Medical output can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods.
The physical replica can be used for diagnostic purposes in the field of orthopaedic, maxillofacial and cardiovascular applications.
Mimics Medical should be used in conjunction with expert clinical judgement.
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/K183105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183105: Mimics Medical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183105
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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