510(k) · Cleared
ClearedSurgiCase Viewer
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 May 11, 2017 as substantially equivalent to K113599 (Materialise NV, 2012) and 1 other predicate after an 87-day review. Its family tree reaches back 6 generations to 1993. 3 later devices descend from it.
- Decided
- May 11, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K924630 (1993). 11 ancestors in all, the oldest K924810 (1993). 3 later devices descend from it, 2 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 backK112389 Surgicase Connect, Surgicase GuideMaterialise NV · 2012
- 1 generation backK132290 Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesMaterialise NV · 2014
- This deviceK170419 SurgiCase ViewerMaterialise NV · 2017
- Descendant · cites it directly · 1 of its ownK213684 SurgiCase ViewerMaterialise NV · 2022
- Descendant · 2 generations on · 0 of its ownK260206 SkeletonPlannerUPlanner B.V. - Presurgeo · 2026
- Descendant · cites it directly · 0 of its ownK260116 CustoMED ViewerCustoMED, Ltd. · 2026
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 |
|---|---|---|---|---|---|
| −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 | K112389 | Surgicase Connect, Surgicase Guide | Materialise NV | 2012 | — |
| −1 | K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides | Materialise NV | 2014 | — |
| 0 (this device) | K170419 | SurgiCase Viewer | Materialise NV | 2017 | — |
| +1 | K213684 | SurgiCase Viewer | Materialise NV | 2022 | — |
| +2 | K260206 | SkeletonPlanner | UPlanner B.V. - Presurgeo | 2026 | — |
| +1 | K260116 | CustoMED Viewer | CustoMED, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K113599 | Surgicase ConnectSummary page 4…ietary or model name SurgiCase Connect for iPad Zimmer Patient Specific Instrument 510(k) number K113599 System 2.5 Decision date April 27, 2012 Classification… | 2012 |
| * | K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesSummary page 5…rade or proprietary or model name SurgiCase Connect Zimmer Patient Specific Instrument 510(k) K132290 Systemnumber 2.5 Decision date April 10, 2014 Classific… | 2014 |
| † | K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | 2015 |
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 24 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K213684 (Materialise NV, 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Viewer is intended to be used as a software interface to assist in visualization and communication of treatment options.
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/K170419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170419: SurgiCase Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170419
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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