510(k) · Cleared
ClearedIPS CaseDesigner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · LLZ System, Image Processing, Radiological
Cleared on Nov 10, 2016 as substantially equivalent to K052424 (Medicim NV, 2006) and 1 other predicate after a 149-day review. Its family tree reaches back 5 generations to 1993. 3 later devices descend from it.
- Decided
- Nov 10, 2016
- Review
- 149 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K924630 (1993). 7 ancestors in all, the oldest K924810 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 4 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 3 generations backK033849 Simplant SystemMaterialise NV · 2004
- 2 generations backK073449 SurgicaseMaterialise NV · 2008
- 1 generation backK111641 Surgicase Orthognathic Software WizardMaterialise NV · 2011
- This deviceK161634 IPS CaseDesignerNobel Biocare AB · 2016
- Descendant · cites it directly · 1 of its ownK200810 IPS CaseDesignerNobel Biocare AB · 2020
- Descendant · 2 generations on · 0 of its ownK230276 TECHFIT DISRP® SystemTechfit Digital Surgery · 2023
- Descendant · cites it directly · 0 of its ownK212981 MirrorMe3D Modeling SystemMirrorme3D, LLC · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −4 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −3 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −2 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −1 | K111641 | Surgicase Orthognathic Software Wizard | Materialise NV | 2011 | — |
| 0 (this device) | K161634 | IPS CaseDesigner | Nobel Biocare AB | 2016 | — |
| +1 | K200810 | IPS CaseDesigner | Nobel Biocare AB | 2020 | — |
| +2 | K230276 | TECHFIT DISRP® System | Techfit Digital Surgery | 2023 | — |
| +1 | K212981 | MirrorMe3D Modeling System | Mirrorme3D, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K052424 | MaxilimSummary page 4…gulatory Class: II Product Code: LLZ III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate Maxilim, Medicim NV, K052424 Additional Predicates Surgicase Orthognathic Software Wizard, Materialise N.V., K111641 IV. Device Descri… | 2006 |
| * | K111641 | Surgicase Orthognathic Software WizardSummary page 4…to the following devices: Primary Predicate Maxilim, Medicim NV, K052424 Additional Predicates Surgicase Orthognathic Software Wizard, Materialise N.V., K111641 IV. Device Description The IPS CaseDesigner software is a tool for the virtual planning of orthognathic surgery.… | 2011 |
What descends from it? (3)
2 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 23 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K200810 (Nobel Biocare AB, 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K052424.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of cranio-maxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161634: IPS CaseDesigner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161634
Report an extraction error
Are you the manufacturer?
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