510(k) · Cleared
ClearedSurgicase
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 Apr 16, 2008 as substantially equivalent to K033849 (Materialise NV, 2004) after a 128-day review. Its family tree reaches back 3 generations to 1993. 143 later devices descend from it.
- Decided
- Apr 16, 2008
- Review
- 128 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). 143 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 deviceK073449 SurgicaseMaterialise NV · 2008
- Descendant · cites it directly · 99 of its ownK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
- Descendant · cites it directly · 71 of its ownK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- Descendant · 2 generations on · 60 of its ownK121640 Zimmer Patient Specific Instruments SystemMaterialise NV · 2012 · Recalled
- Descendant · cites it directly · 59 of its ownK112389 Surgicase Connect, Surgicase GuideMaterialise NV · 2012
- Descendant · 2 generations on · 39 of its ownK131129 Cas Psi ShoulderZimmer Cas · 2013
Showing 5 of 143 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 143 · See all- K102795Signature Planner; Signature GuidesMaterialise NV · 2011 · cites it directly99descendants
- K111863Signature Planner,Signature GuidesMaterialise NV · 2012 · cites it directly71descendants
- K121640Zimmer Patient Specific Instruments SystemMaterialise NV · 2012 · 2 generations on60descendants
- K112389Surgicase Connect, Surgicase GuideMaterialise NV · 2012 · cites it directly59descendants
- K131129Cas Psi ShoulderZimmer Cas · 2013 · 2 generations on39descendants
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) | K073449 | Surgicase | Materialise NV | 2008 | — |
| +1 | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | 4 |
| +1 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| +2 | K121640 | Zimmer Patient Specific Instruments System | Materialise NV | 2012 | 1 |
| +1 | K112389 | Surgicase Connect, Surgicase Guide | Materialise NV | 2012 | — |
| +2 | K131129 | Cas Psi Shoulder | Zimmer Cas | 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 |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 11 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 9 | 0 |
| 2022 | 10 | 0 |
| 2023 | 17 | 0 |
| 2024 | 12 | 0 |
| 2025 | 16 | 0 |
| 2026 | 11 | 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…tially equivalent in material, design, and function to the SimPlant product from Materialise Dental which was cleared by FDA under 510(k) K033849 on May 25, 2004. DEVICE DESCRIPTION The Materialise SurgiCase System is intended for use as a software i… | 2004 |
What descends from it? (143)
See all 1437 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102795 | Signature Planner; Signature Guides | 2011 | 99 |
| K111863 | Signature Planner,Signature Guides | 2012 | 71 |
| K112389 | Surgicase Connect, Surgicase Guide | 2012 | 59 |
| K133367 | Orthovis Preoperative Plan | 2013 | 23 |
| K111641 | Surgicase Orthognathic Software Wizard | 2011 | 6 |
| K113599 | Surgicase Connect | 2012 | 4 |
| K140337 | Brightmatter Planning Software | 2014 | 1 |
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 15 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, K102795 (Materialise NV, 2011) has gone furthest, with 99 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. 2008, 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?
The Materialise SuurgiCase' 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 Imaging scanner. It is also intended as pre-operative software for simulating I evaluating implant placement and surgical treatment options.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073449: Surgicase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073449
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