510(k) · Cleared
ClearedMimics Enlight CMF
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 May 31, 2024 as substantially equivalent to K183105 (Materialise NV, 2019) and 2 other predicates after a 564-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- May 31, 2024
- Review
- 564 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K924630 (1993). 15 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 7 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 5 generations backK033849 Simplant SystemMaterialise NV · 2004
- 4 generations backK060950 3MATICMaterialise NV · 2006
- 3 generations backK120956 VSP SystemMedical Modeling, Inc. · 2012
- 2 generations backK133907 VSP SystemMedical Modeling, Inc. · 2014 · Recalled
- 1 generation backK212570 OsteoPlan SystemOsteomed, LLC · 2022
- This deviceK223427 Mimics Enlight CMFMaterialise NV · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −6 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −5 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −4 | K060950 | 3MATIC | Materialise NV | 2006 | — |
| −3 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
| −2 | K133907 | VSP System | Medical Modeling, Inc. | 2014 | 1 |
| −1 | K212570 | OsteoPlan System | Osteomed, LLC | 2022 | — |
| 0 (this device) | K223427 | Mimics Enlight CMF | Materialise NV | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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? (3)
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 5…ed: Trade or proprietary or model name Materialise Mimics Medical, Mimics Medical, Mimics 510(k) number K183105 Decision date 03/27/2019 Classification product code LLZ… | 2019 |
| * | K111641 | Surgicase Orthognathic Software WizardSummary page 6…ference device Trade or proprietary or model name SurgiCase, SurgiCase CMF, ProPlan CMF 510(k) number K111641 Decision date 09/26/2011 Classification product code LL… | 2011 |
| * | K212570 | OsteoPlan SystemSummary page 6…Materialise N.V. Trade or proprietary or model name OsteoPlan System 510(k) number K212570 Decision date 02/12/2022 Classification product code DZ… | 2022 |
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 31 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 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. 2024, 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?
Materialise Mimics Enlight CMF: Mimics Enlight CMF is intended for use as a software interface and imaging segmentation system for the transfer of medical imaging information to an output file. Mimics Enlight CMF is also intended to support the diagnostic and treatment planning process of maxillofacial procedures. For this purpose, Mimics Enlight CMF provides visualization, measurement and design tools. The Mimics Enlight CMF output file can be used for…
Read the full statement (115 words)
Materialise Mimics Enlight CMF:
Mimics Enlight CMF is intended for use as a software interface and imaging segmentation system for the transfer of medical imaging information to an output file.
Mimics Enlight CMF is also intended to support the diagnostic and treatment planning process of maxillofacial procedures. For this purpose, Mimics Enlight CMF provides visualization, measurement and design tools.
The Mimics Enlight CMF output file can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The fabricated output can be used for diagnostic purposes in the field of maxillofacial applications.
Mimics Enlight CMF should be used in conjunction with other diagnostic tools and expert clinical judgement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223427 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223427: Mimics Enlight CMF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223427
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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