510(k) · Cleared
ClearedSimplant DR. James
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 Feb 8, 2006 as substantially equivalent to K033849 (Materialise NV, 2004) after a 47-day review. Its family tree reaches back 3 generations to 1993. 68 later devices descend from it.
- Decided
- Feb 8, 2006
- Review
- 47 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). 68 later devices descend from it, 7 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 deviceK053592 Simplant DR. JamesMaterialise NV · 2006
- Descendant · cites it directly · 38 of its ownK070803 InvivodentalAnatomage, Inc. · 2007
- Descendant · 2 generations on · 24 of its ownK123519 Invivo DentalAnatomage, Inc. · 2013
- Descendant · cites it directly · 20 of its ownK110300 Simplant 2011Materialise Dental NV · 2011
- Descendant · 3 generations on · 14 of its ownK140713 Planmeca RomexisPlanmeca Oy · 2014
- Descendant · 4 generations on · 13 of its ownK162799 CliniviewPalodex Group OY · 2017
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K070803InvivodentalAnatomage, Inc. · 2007 · cites it directly38descendants
- K123519Invivo DentalAnatomage, Inc. · 2013 · 2 generations on24descendants
- K110300Simplant 2011Materialise Dental NV · 2011 · cites it directly20descendants
- K140713Planmeca RomexisPlanmeca Oy · 2014 · 3 generations on14descendants
- K162799CliniviewPalodex Group OY · 2017 · 4 generations on13descendants
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) | K053592 | Simplant DR. James | Materialise NV | 2006 | — |
| +1 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| +2 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| +1 | K110300 | Simplant 2011 | Materialise Dental NV | 2011 | — |
| +3 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| +4 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 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…NAME: System, Image Processing. This product uses images acquired from Computerized Tomography (CT) scanners. PREDiCATE DEVICE SimPlant System (K<033849) FUNCTION The modified Sim-Plant System is used to transfer images from a medical scanner and to perform a segmentation of the… | 2004 |
What descends from it? (68)
See all 687 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 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, K070803 (Anatomage, Inc., 2007) has gone furthest, with 38 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.
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 Materialise SimPlant System 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 scanner. It is also used as a
pre-operative software for simulating /evaluating dental implant placement and surgical
treatment options.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053592 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053592: Simplant DR. James.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053592
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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