510(k) · Cleared
ClearedMimics
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 Apr 2, 2008 as substantially equivalent to K033849 (Materialise NV, 2004) after a 114-day review. Its family tree reaches back 3 generations to 1993. 141 later devices descend from it.
- Decided
- Apr 2, 2008
- Review
- 114 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924630 (1993). 4 ancestors in all, the oldest K924810 (1993). 141 later devices descend from it, 9 citing it directly.
- Root · 3 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 2 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 1 generation backK033849 Simplant SystemMaterialise NV · 2004
- This deviceK073468 MimicsMaterialise NV · 2008
- Descendant · cites it directly · 41 of its ownK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- Descendant · cites it directly · 40 of its ownK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- Descendant · 2 generations on · 37 of its ownK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- Descendant · cites it directly · 34 of its ownK183105 Mimics MedicalMaterialise NV · 2019
- Descendant · cites it directly · 28 of its ownK120956 VSP SystemMedical Modeling, Inc. · 2012
Showing 5 of 141 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 141 · See all- K093269Procedure Rehearsal StudioSimbionix, Ltd. · 2010 · cites it directly41descendants
- K112387Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011 · cites it directly40descendants
- K123023Surgery Rehearsal PlatformSurgical Theater, LLC · 2013 · 2 generations on37descendants
- K183105Mimics MedicalMaterialise NV · 2019 · cites it directly34descendants
- K120956VSP SystemMedical Modeling, Inc. · 2012 · cites it directly28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −2 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −1 | K033849 | Simplant System | Materialise NV | 2004 | — |
| 0 (this device) | K073468 | Mimics | Materialise NV | 2008 | — |
| +1 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| +1 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| +2 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| +1 | K183105 | Mimics Medical | Materialise NV | 2019 | — |
| +1 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 9 | 0 |
| 2020 | 11 | 0 |
| 2021 | 12 | 0 |
| 2022 | 15 | 0 |
| 2023 | 24 | 0 |
| 2024 | 12 | 0 |
| 2025 | 14 | 0 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K033849 | Simplant SystemSummary page 1…to be substantially equivalent in material, design, and function to the Sim Plant product from Materialise Dental which was cleared by FDA under 51 0(k) K033849 on May 25, 2004. DEVICE DESCRIPTION The Materialise Mimics software is intended for use as a software interface and… | 2004 |
What descends from it? (141)
See all 1419 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093269 | Procedure Rehearsal Studio | 2010 | 41 |
| K112387 | Procedure Rehearsal Studio (TM) | 2011 | 40 |
| K183105 | Mimics Medical | 2019 | 34 |
| K120956 | VSP System | 2012 | 28 |
| K132636 | Dyonics Plan Hip Impingement Planning System | 2013 | 14 |
| K173619 | Mimics inPrint | 2018 | 13 |
| K161841 | D2P | 2017 | 8 |
| K142779 | Scanip; Scanip: Medical Edition; Scanip: Med | 2015 | 4 |
| K124051 | The Vault System | 2013 | 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 15 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K093269 (Simbionix, Ltd., 2010) has gone furthest, with 41 descendants of its own.
- 19 other devices also cite its predicate K033849.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 is intended for use as a software interface and image segmentation system for the
transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic
Resonance Imaging scanner to an output file. It is also used as pre-operative software for
simulating /evaluating surgical treatment options.
Mimics is not intended to be used for mammography imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073468 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073468: Mimics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073468
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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