510(k) · Cleared
ClearedVSP Cranial System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3D Systems, Inc. · PPT Cranial Surgical Planning And Instrument Guides
Cleared on Sep 23, 2016 as substantially equivalent to K133907 (Medical Modeling, Inc., 2014) after a 498-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Sep 23, 2016
- Review
- 498 days
- Class
- Class II
- Product code
- PPT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924630 (1993). 11 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- 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 backK060950 3MATICMaterialise NV · 2006
- 2 generations backK120956 VSP SystemMedical Modeling, Inc. · 2012
- 1 generation backK133907 VSP SystemMedical Modeling, Inc. · 2014 · Recalled
- This deviceK151285 VSP Cranial System3D Systems, Inc. · 2016
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 | K060950 | 3MATIC | Materialise NV | 2006 | — |
| −2 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
| −1 | K133907 | VSP System | Medical Modeling, Inc. | 2014 | 1 |
| 0 (this device) | K151285 | VSP Cranial System | 3D Systems, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 PPT? 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 PPT device
- #1 K253308 Materialise Personalized Guides and Models for…score 12.7 · 8 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K133907 | VSP SystemSummary page 4…, 21 CFR 882.4310 Product Code: PPT 4. PREDICATE DEVICE • VSP® System, 3D Systems (K133907) 5. DESCRIPTION OF THE DEVICE The 3D Systems VSP® Cranial System is a collecti… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K133907.
How does its category compare?
All PPT devicesPPT Cranial Surgical Planning And Instrument Guides: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PPT
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PPT
Too few PPT 510(k)s in any year since 2007 to give a median.
Recalls per year · PPT
No recall names PPT since 2007.
Adverse event reports per year · PPT
No MAUDE report names PPT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The 3D Systems, Inc. VSP Cranial System is intended for use as a collection of software to provide image segmentation and transfer of imaging information from a CT based medical scanner. The input data file is processed by the VSP Cranial System and the result is an output data file that may then be provided as digital models or used as input in the production of physical outputs including anatomical models, templates, and surgical guides for use in the marking or cutting of cranial bone in cranial surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151285: VSP Cranial System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151285
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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