510(k) Report

510(k) · Cleared

Cleared

VSP System

K120956510(k) TraditionalCleared Dec 12, 2012257-day reviewClass II21 CFR 872.4120

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medical Modeling, Inc. · DZJ Driver, Wire, And Bone Drill, Manual

Cleared on Dec 12, 2012 as substantially equivalent to K970617 (Materialise NV, 1997) and 3 other predicates after a 257-day review. Its family tree reaches back 4 generations to 1993. 28 later devices descend from it.

Decided
Dec 12, 2012
Review
257 days
Class
Class II
Product code
DZJ
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K924630 (1993). 9 ancestors in all, the oldest K924810 (1993). 28 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2008: 2 other ancestors2010: 1 other ancestor1993: 1 other ancestor2022: 4 descendants cleared2020: 6 descendants cleared2018: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant cleared2019: 2 descendants cleared2021: 2 descendants cleared2023: 4 descendants cleared2024: 3 descendants cleared2025: 1 descendant cleared2026: 2 descendants clearedK924630 · Surgicad (TM) View (TM) · Surgicad Corp. · 1993K970617 · CT-Modeller System · Materialise NV · 1997K033849 · Simplant System · Materialise NV · 2004K060950 · 3MATIC · Materialise NV · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 9 descendants3 generations forward: 10 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K060950 · 3MATIC · Materialise NV · 2006K033849 · Simplant System · Materialise NV · 2004K970617 · CT-Modeller System · Materialise NV · 1997K924630 · Surgicad (TM) View (TM) · Surgicad Corp. · 19930+5
  1. Root · 4 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
  2. 3 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
  3. 2 generations backK033849 Simplant SystemMaterialise NV · 2004
  4. 1 generation backK060950 3MATICMaterialise NV · 2006
  5. This deviceK120956 VSP SystemMedical Modeling, Inc. · 2012
  6. Descendant · cites it directly · 12 of its ownK181241 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2018
  7. Descendant · cites it directly · 8 of its ownK133907 VSP SystemMedical Modeling, Inc. · 2014 · Recalled
  8. Descendant · 2 generations on · 7 of its ownK182789 KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2019
  9. Descendant · cites it directly · 3 of its ownK192282 MedCAD® AccuPlan® SystemMedcad · 2020
  10. Descendant · 2 generations on · 3 of its ownK192192 VSP System3D Systems · 2020

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12016: 12018: 12019: 22020: 62021: 22022: 42023: 42024: 32025: 12026: 2
2013high 6 (2020) · low 0 (2015)2026

Most influential descendants

Showing 5 of 28 · See all
  • K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2018 · cites it directly12descendants
  • K133907VSP SystemMedical Modeling, Inc. · 2014 · cites it directly8descendants
  • K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. · 2019 · 2 generations on7descendants
  • K192282MedCAD® AccuPlan® SystemMedcad · 2020 · cites it directly3descendants
  • K192192VSP System3D Systems · 2020 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K924630Surgicad (TM) View (TM)Surgicad Corp.1993—
−3K970617CT-Modeller SystemMaterialise NV1997—
−2K033849Simplant SystemMaterialise NV2004—
−1K0609503MATICMaterialise NV2006—
0 (this device)K120956VSP SystemMedical Modeling, Inc.2012—
+1K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.2018—
+1K133907VSP SystemMedical Modeling, Inc.20141
+2K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.2019—
+1K192282MedCAD® AccuPlan® SystemMedcad2020—
+2K192192VSP System3D Systems2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
200820
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201610
201810
201920
202060
202120
202240
202340
202430
202510
202620
FIG. 1 — Lineage of K120956, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243637 Materialise Personalized Guides and Models for…score 13.7 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K970617CT-Modeller System
Summary page 1
…4 PREDICATE DEVICES: 4.1 The VSP® System is claimed to be substantially equivalent to the following legally marketed predicate devices: 4.1.1 CT Modeller (K970617), manufactured by Materialise®D 4.1.2 SurgiCase® Guides (K1 03136), manufactured by Materialise®D 4.1.3 SimPlant® 3Ma…
Materialise NV1997—
*K103136Surgicase CMF, Surgicase Connect, Surgicase Guide
Summary page 1
…lly equivalent to the following legally marketed predicate devices: 4.1.1 CT Modeller (K970617), manufactured by Materialise®D 4.1.2 SurgiCase® Guides (K1 03136), manufactured by Materialise®D 4.1.3 SimPlant® 3Matic® (K060950), manufactured by Materialise®g 4.1.4 MIMICS@ (K0734…
Materialise NV20111
*K0609503MATIC
Summary page 1
…: 4.1.1 CT Modeller (K970617), manufactured by Materialise®D 4.1.2 SurgiCase® Guides (K1 03136), manufactured by Materialise®D 4.1.3 SimPlant® 3Matic® (K060950), manufactured by Materialise®g 4.1.4 MIMICS@ (K073468), manufactured by Materialise® 5 PERFORMANCE STANDARDS: 5.1 There…
Materialise NV2006—
*K073468Mimics
Summary page 1
…ise®D 4.1.2 SurgiCase® Guides (K1 03136), manufactured by Materialise®D 4.1.3 SimPlant® 3Matic® (K060950), manufactured by Materialise®g 4.1.4 MIMICS@ (K073468), manufactured by Materialise® 5 PERFORMANCE STANDARDS: 5.1 There are no performance standards for this device type === Page 2…
Materialise NV2008—

Also cleared against K970617: 1 other device →

What descends from it? (28)

See all 28

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.201812
K133907VSP SystemMedical Modeling, Inc.20148
K192282MedCAD® AccuPlan® SystemMedcad20203
K212570OsteoPlan SystemOsteomed, LLC20221
K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch20200
K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130

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 19 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K181241 (KLS-Martin L.P., 2018) has gone furthest, with 12 descendants of its own.
  • 1 other device also cites its predicate K970617.

How does its category compare?

All DZJ devices

DZJ Driver, Wire, And Bone Drill, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · DZJ

1in 2025

2012: 12014: 12015: 22018: 22019: 12020: 42021: 32022: 32023: 32024: 12025: 12026 (partial year): 2
2007high 4 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZJ

142in 2023

2020: 379 days median2021: 403 days median2022: 179 days median2023: 142 days median
2007high 403 (2021) · low 142 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZJ

1in 2013

2011: 52013: 1
2007high 5 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZJ

14in 2025

2008: 102009: 1422010: 5172011: 5782012: 6212013: 8092014: 5392015: 182016: 162017: 92018: 82019: 42020: 172021: 222022: 232023: 222024: 132025: 14
2007high 809 (2013) · low 0 (2007)2025

MAUDE reports naming product code DZJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—010
20090—0142
20100—0517
20110—5578
20121—0621
20130—1809
20141—0539
20152—018
20160—016
20170—09
20182—08
20191—04
20204379017
20213403022
20223179023
20233142022
20241—013
20251—014
20262—0—

What is it indicated for?

The Medical Modeling VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the VSP® 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 maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

Indications for use as stated in the FDA summary.

Also cleared against K970617

1 other device cites the same predicate.

  • K033849Simplant SystemMaterialise NV · 2004

More from Medical Modeling, Inc.

2 FDA decisions under this applicant name. See the company

  • K133907VSP SystemMedical Modeling, Inc. · 20141 recall

Recent decisions in DZJ

The DZJ category page

  • K260913CMF Titanium SplintsMaterialise NV · 2026
  • K261826VSP System (Titanium Palatal Splint)3D Systems, Inc. · 2026
  • K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV · 2025
  • K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc. · 2024
  • K231520tmCMF SolutionTechmah Cmf · 2023

https://510kreport.com/device/K120956 · printed Nov 5, 2026

Cite this page

510(k) Report. “K120956: 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/K120956

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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