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 Oct 8, 2020 as substantially equivalent to K161634 (Nobel Biocare AB, 2016) after a 195-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Oct 8, 2020
- Review
- 195 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924630 (1993). 8 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK073449 SurgicaseMaterialise NV · 2008
- 2 generations backK111641 Surgicase Orthognathic Software WizardMaterialise NV · 2011
- 1 generation backK161634 IPS CaseDesignerNobel Biocare AB · 2016
- This deviceK200810 IPS CaseDesignerNobel Biocare AB · 2020
- Descendant · cites it directly · 0 of its ownK230276 TECHFIT DISRP® SystemTechfit Digital Surgery · 2023
Most influential descendants
Showing 1 of 1 · See all- K230276TECHFIT DISRP® SystemTechfit Digital Surgery · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −2 | K111641 | Surgicase Orthognathic Software Wizard | Materialise NV | 2011 | — |
| −1 | K161634 | IPS CaseDesigner | Nobel Biocare AB | 2016 | — |
| 0 (this device) | K200810 | IPS CaseDesigner | Nobel Biocare AB | 2020 | — |
| +1 | K230276 | TECHFIT DISRP® System | Techfit Digital Surgery | 2023 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K161634 | IPS CaseDesignerSummary page 4…ry Class: II Product Code: LLZ III. Predicate Device Substantial equivalence is claimed to the following devices: Predicate Device: IPS CaseDesigner Predicate 510(k): K161634 Compay: NobelBiocare AB Reference device: KLS Martin Individual Patient Solutions (IPS) Planning System Reference device 510(k):… | 2016 |
| † | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230276 | TECHFIT DISRP® System | 2023 | 0 |
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 27 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K230276 (Techfit Digital Surgery, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K161634.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 craniomaxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200810: 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/K200810
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