510(k) · Cleared
ClearedSimplant System
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 25, 2004 as substantially equivalent to K924810 (Columbia Scientific, Inc., 1993) and 1 other predicate after a 166-day review. Its family tree reaches back 2 generations to 1993. 379 later devices descend from it.
- Decided
- May 25, 2004
- Review
- 166 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K924630 (1993). 3 ancestors in all, the oldest K924810 (1993). 379 later devices descend from it, 20 citing it directly.
- Root · 2 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 1 generation backK970617 CT-Modeller SystemMaterialise NV · 1997
- This deviceK033849 Simplant SystemMaterialise NV · 2004
- Descendant · cites it directly · 143 of its ownK073449 SurgicaseMaterialise NV · 2008
- Descendant · cites it directly · 141 of its ownK073468 MimicsMaterialise NV · 2008
- Descendant · 2 generations on · 99 of its ownK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
- Descendant · 2 generations on · 71 of its ownK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- Descendant · cites it directly · 68 of its ownK053592 Simplant DR. JamesMaterialise NV · 2006
Showing 5 of 379 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 379 · See all- K073449SurgicaseMaterialise NV · 2008 · cites it directly143descendants
- K073468MimicsMaterialise NV · 2008 · cites it directly141descendants
- K102795Signature Planner; Signature GuidesMaterialise NV · 2011 · 2 generations on99descendants
- K111863Signature Planner,Signature GuidesMaterialise NV · 2012 · 2 generations on71descendants
- K053592Simplant DR. JamesMaterialise NV · 2006 · cites it directly68descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −1 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| 0 (this device) | K033849 | Simplant System | Materialise NV | 2004 | — |
| +1 | K073449 | Surgicase | Materialise NV | 2008 | — |
| +1 | K073468 | Mimics | Materialise NV | 2008 | — |
| +2 | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | 4 |
| +2 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| +1 | K053592 | Simplant DR. James | Materialise NV | 2006 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 9 | 0 |
| 2012 | 12 | 0 |
| 2013 | 16 | 0 |
| 2014 | 13 | 0 |
| 2015 | 12 | 0 |
| 2016 | 17 | 0 |
| 2017 | 22 | 0 |
| 2018 | 20 | 0 |
| 2019 | 23 | 0 |
| 2020 | 29 | 0 |
| 2021 | 24 | 0 |
| 2022 | 26 | 0 |
| 2023 | 43 | 0 |
| 2024 | 25 | 0 |
| 2025 | 33 | 0 |
| 2026 | 33 | 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 |
|---|---|---|---|
| * | K924810 | Sim/PlantSummary page 1…ial, design, and function to the SIM/Plant product which was acquired by Materialise from Columbia Scientific, Inc. and cleared by FDA under 510(k) K924810 on January 15, 1993. The SimPlant System is claimed to be substantially equivalent in material, design,… | 1993 |
| * | K970617 | CT-Modeller SystemSummary page 1…to be substantially equivalent in material, design, and function to the CT-Modeller product from Materialise which was cleared by FDA under 510(k) K970617 on April 21, 1997 SirePlant System 510(k) -- Premarket Notification… | 1997 |
What descends from it? (379)
See all 37920 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073449 | Surgicase | 2008 | 143 |
| K073468 | Mimics | 2008 | 141 |
| K053592 | Simplant DR. James | 2006 | 68 |
| K053155 | Vimplant | 2005 | 63 |
| K042212 | Implantmaster | 2004 | 44 |
| K060267 | Virtual Implant Placement (Vip) Dental Implant Surgery Planning Software | 2006 | 43 |
| K070803 | Invivodental | 2007 | 38 |
| K060950 | 3MATIC | 2006 | 31 |
| K071636 | Codiagnostix (R) 5.72 | 2007 | 21 |
| K052424 | Maxilim | 2006 | 17 |
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 11 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073449 (Materialise NV, 2008) has gone furthest, with 143 descendants of its own.
- 1 other device also cites its predicate K924810.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SimPlant system is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is indicated 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 scanner. It is also indicated for use as a planning and simulation software for dental implant placement and surgical treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033849 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033849: Simplant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033849
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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