510(k) · Cleared
ClearedMaxilim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicim NV · LLZ System, Image Processing, Radiological
Cleared on Mar 31, 2006 as substantially equivalent to K033849 (Materialise NV, 2004) after a 210-day review. Its family tree reaches back 3 generations to 1993. 17 later devices descend from it.
- Decided
- Mar 31, 2006
- Review
- 210 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). 17 later devices descend from it, 3 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 deviceK052424 MaxilimMedicim NV · 2006
- Descendant · cites it directly · 8 of its ownK113732 Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan…Brainlab AG · 2012
- Descendant · 2 generations on · 5 of its ownK170816 Elements Image Fusion, Elements Cranial Distortion Correction…Brainlab AG · 2017
- Descendant · 2 generations on · 3 of its ownK212420 Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements…Brainlab AG · 2021
- Descendant · cites it directly · 3 of its ownK161634 IPS CaseDesignerNobel Biocare AB · 2016
- Descendant · cites it directly · 3 of its ownK123976 NobelclinicianNobel Biocare AB · 2013
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K113732Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)Brainlab AG · 2012 · cites it directly8descendants
- K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG · 2017 · 2 generations on5descendants
- K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG · 2021 · 2 generations on3descendants
- K161634IPS CaseDesignerNobel Biocare AB · 2016 · cites it directly3descendants
- K123976NobelclinicianNobel Biocare AB · 2013 · cites it directly3descendants
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) | K052424 | Maxilim | Medicim NV | 2006 | — |
| +1 | K113732 | Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View… | Brainlab AG | 2012 | — |
| +2 | K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine… | Brainlab AG | 2017 | — |
| +2 | K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements… | Brainlab AG | 2021 | — |
| +1 | K161634 | IPS CaseDesigner | Nobel Biocare AB | 2016 | — |
| +1 | K123976 | Nobelclinician | Nobel Biocare AB | 2013 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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…Image Processing (3) Predicate Devices: The predicate devices are identified as the following: Simplant System by Materialise NV, 510(k) K033849. The subject device and predicate device have the same indications for use (planning for surgical treatment), simila… | 2004 |
What descends from it? (17)
See all 173 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 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K113732 (Brainlab AG, 2012) has gone furthest, with 8 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?
Maxilim is indicated 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. It is also indicated for use as a planning and simulation software for surgical treatment, specifically maxillofacial treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052424: Maxilim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052424
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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