510(k) · Cleared
ClearedSurgicase Orthognathic Software Wizard
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 Sep 26, 2011 as substantially equivalent to K073449 (Materialise NV, 2008) after a 105-day review. Its family tree reaches back 4 generations to 1993. 6 later devices descend from it.
- Decided
- Sep 26, 2011
- Review
- 105 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924630 (1993). 5 ancestors in all, the oldest K924810 (1993). 6 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 3 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 2 generations backK033849 Simplant SystemMaterialise NV · 2004
- 1 generation backK073449 SurgicaseMaterialise NV · 2008
- This deviceK111641 Surgicase Orthognathic Software WizardMaterialise NV · 2011
- Descendant · cites it directly · 3 of its ownK161634 IPS CaseDesignerNobel Biocare AB · 2016
- Descendant · 2 generations on · 1 of its ownK200810 IPS CaseDesignerNobel Biocare AB · 2020
- Descendant · cites it directly · 0 of its ownK223427 Mimics Enlight CMFMaterialise NV · 2024
- Descendant · 3 generations on · 0 of its ownK230276 TECHFIT DISRP® SystemTechfit Digital Surgery · 2023
- Descendant · 2 generations on · 0 of its ownK212981 MirrorMe3D Modeling SystemMirrorme3D, LLC · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161634IPS CaseDesignerNobel Biocare AB · 2016 · cites it directly3descendants
- K200810IPS CaseDesignerNobel Biocare AB · 2020 · 2 generations on1descendant
- K223427Mimics Enlight CMFMaterialise NV · 2024 · cites it directly0descendants
- K230276TECHFIT DISRP® SystemTechfit Digital Surgery · 2023 · 3 generations on0descendants
- K212981MirrorMe3D Modeling SystemMirrorme3D, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −3 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −2 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −1 | K073449 | Surgicase | Materialise NV | 2008 | — |
| 0 (this device) | K111641 | Surgicase Orthognathic Software Wizard | Materialise NV | 2011 | — |
| +1 | K161634 | IPS CaseDesigner | Nobel Biocare AB | 2016 | — |
| +2 | K200810 | IPS CaseDesigner | Nobel Biocare AB | 2020 | — |
| +1 | K223427 | Mimics Enlight CMF | Materialise NV | 2024 | — |
| +3 | K230276 | TECHFIT DISRP® System | Techfit Digital Surgery | 2023 | — |
| +2 | K212981 | MirrorMe3D Modeling System | Mirrorme3D, LLC | 2022 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K073449 | SurgicaseSummary page 1…logical Product code LLZ (21 CFR 892.2050) Predicate device Trade or proprietary or model name SurgiCase 510(k) number K073449 Decision date 2008/04/16 Product code [[2 Manufacturer Mat… | 2008 |
What descends from it? (6)
3 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 18 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K161634 (Nobel Biocare AB, 2016) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K073449.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options,
based on imaging information from a medical scanner such as a CT scanner or a Magnetic
Resonance Imaging (MRI) scanner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111641: Surgicase Orthognathic Software Wizard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111641
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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