510(k) · Cleared
Recalled · Class II · 2022VSP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Modeling, Inc. · DZJ Driver, Wire, And Bone Drill, Manual
Cleared on Jan 22, 2014 as substantially equivalent to K120956 (Medical Modeling, Inc., 2012) after a 30-day review. Its family tree reaches back 5 generations to 1993. 8 later devices descend from it. It has been recalled once.
- Decided
- Jan 22, 2014
- Review
- 30 days
- Class
- Class II
- Product code
- DZJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924630 (1993). 10 ancestors in all, the oldest K924810 (1993). 8 later devices descend from it, 4 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 backK060950 3MATICMaterialise NV · 2006
- 1 generation backK120956 VSP SystemMedical Modeling, Inc. · 2012
- This deviceK133907 VSP SystemMedical Modeling, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK192192 VSP System3D Systems · 2020
- Descendant · cites it directly · 1 of its ownK212570 OsteoPlan SystemOsteomed, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK210347 VSP System3D Systems · 2021
- Descendant · 2 generations on · 0 of its ownK261826 VSP System (Titanium Palatal Splint)3D Systems, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK223427 Mimics Enlight CMFMaterialise NV · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K192192VSP System3D Systems · 2020 · cites it directly3descendants
- K212570OsteoPlan SystemOsteomed, LLC · 2022 · cites it directly1descendant
- K210347VSP System3D Systems · 2021 · 2 generations on1descendant
- K261826VSP System (Titanium Palatal Splint)3D Systems, Inc. · 2026 · 2 generations on0descendants
- K223427Mimics Enlight CMFMaterialise NV · 2024 · 2 generations on0descendants
View 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 | K060950 | 3MATIC | Materialise NV | 2006 | — |
| −1 | K120956 | VSP System | Medical Modeling, Inc. | 2012 | — |
| 0 (this device) | K133907 | VSP System | Medical Modeling, Inc. | 2014 | — |
| +1 | K192192 | VSP System | 3D Systems | 2020 | — |
| +1 | K212570 | OsteoPlan System | Osteomed, LLC | 2022 | — |
| +2 | K210347 | VSP System | 3D Systems | 2021 | — |
| +2 | K261826 | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | 2026 | — |
| +2 | K223427 | Mimics Enlight CMF | Materialise NV | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 DZJ? 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 DZJ device
- #1 K243637 Materialise Personalized Guides and Models for…score 13.7 · 7 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 |
|---|---|---|---|
| * | K120956 | VSP SystemSummary page 1…VSP® System is claimed to be substantially equivalent to the following legally marketed predicate device: 4.1.1 VSP® System, Medical Modeling Inc. (K1 20956) 5 PERFORMANCE STANDARDS 5.1 There are no performance standards for this device type.… | 2012 |
What descends from it? (8)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 17, 2022 | Class II | Z-1510-2022 | Employee error | Scapula Marking Guide (anatomically Shaped) was incorrectly designed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K192192 (3D Systems, 2020) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K120956.
How does its category compare?
All DZJ devicesDZJ Driver, Wire, And Bone Drill, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZJ
142in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZJ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZJ
14in 2025
MAUDE reports naming product code DZJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 142 |
| 2010 | 0 | — | 0 | 517 |
| 2011 | 0 | — | 5 | 578 |
| 2012 | 1 | — | 0 | 621 |
| 2013 | 0 | — | 1 | 809 |
| 2014 | 1 | — | 0 | 539 |
| 2015 | 2 | — | 0 | 18 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 2 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 4 | 379 | 0 | 17 |
| 2021 | 3 | 403 | 0 | 22 |
| 2022 | 3 | 179 | 0 | 23 |
| 2023 | 3 | 142 | 0 | 22 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Medical Modeling VSP(R) System is intended for use as a software system and image segmentation system fir the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the VSP(R) System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxcillofaciall surgery. The VSP(R) System is also intended as a pre-operative software tool for simulating Ievaluating surgical treatment options.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133907 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133907: VSP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133907
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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