510(k) · Cleared
ClearedMirrorMe3D Modeling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mirrorme3D, LLC · LLZ System, Image Processing, Radiological
Cleared on Apr 22, 2022 as substantially equivalent to K183105 (Materialise NV, 2019) and 1 other predicate after a 217-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Apr 22, 2022
- Review
- 217 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K924630 (1993). 10 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 backK073449 SurgicaseMaterialise NV · 2008
- 2 generations backK111641 Surgicase Orthognathic Software WizardMaterialise NV · 2011
- 1 generation backK161634 IPS CaseDesignerNobel Biocare AB · 2016
- This deviceK212981 MirrorMe3D Modeling SystemMirrorme3D, LLC · 2022
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 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −2 | K111641 | Surgicase Orthognathic Software Wizard | Materialise NV | 2011 | — |
| −1 | K161634 | IPS CaseDesigner | Nobel Biocare AB | 2016 | — |
| 0 (this device) | K212981 | MirrorMe3D Modeling System | Mirrorme3D, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K183105 | Mimics MedicalSummary page 4…processing system Classification Code LLZ Regulatory Class II C. PRIMARY, SECONDARY PREDICATE AND REFERENCE DEVICES Primary Predicate Device: K183105, Materialise Mimics Medical Secondary Predicate: K161634, ISP CaseDesigner Reference Device: K192282, MedCAD AccuPlan… | 2019 |
| * | K161634 | IPS CaseDesignerSummary page 4…ory Class II C. PRIMARY, SECONDARY PREDICATE AND REFERENCE DEVICES Primary Predicate Device: K183105, Materialise Mimics Medical Secondary Predicate: K161634, ISP CaseDesigner Reference Device: K192282, MedCAD AccuPlan® System The predicate, the secondary predicate and the r… | 2016 |
| † | K192282 | MedCAD® AccuPlan® System | 2020 |
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 29 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 10 ancestors has a recall.
- 16 other devices also cite its predicate K183105.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The MirrorMe3D Modeling System is intended for use as an image processing system for the transfer of 3D medical images. The MirrorMe3D Modeling System is also intended as a visualization system for measuring and treatment planning for aesthetic facial soft tissue. The input data is processed by the System using off-the-shelf modeling software and the result is an output data file that may then be provided as a digital model or used as input for the…
Read the full statement (142 words)
The MirrorMe3D Modeling System is intended for use as an image processing system for the transfer of 3D medical images. The MirrorMe3D Modeling System is also intended as a visualization system for measuring and treatment planning for aesthetic facial soft tissue. The input data is processed by the System using off-the-shelf modeling software and the result is an output data file that may then be provided as a digital model or used as input for the additive manufacturing of a physical anatomic model, which is not for diagnostic use. The MirrorMe3D Modeling System should only be used in conjunction with expert clinical judgment and is not intended for diagnostic use. MirrorMe3D trained personnel will use off-the-shelf software to assist users in creating the 3D virtual (or digital) model that depicts the surgeon's intended outcome. The anatomic models are not for diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212981: MirrorMe3D Modeling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212981
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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