# K120956: VSP System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Modeling, Inc.
- Decided: Dec 12, 2012 after 257 days
- Product code: DZJ (Driver, Wire, And Bone Drill, Manual)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924630 (1993). 9 ancestors in all.
28 later devices descend from it; 6 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970617: CT-Modeller System, Materialise NV (1997) Summary page 1.
- K103136: Surgicase CMF, Surgicase Connect, Surgicase Guide, Materialise NV (2011) Summary page 1.
- K060950: 3MATIC, Materialise NV (2006) Summary page 1.
- K073468: Mimics, Materialise NV (2008) Summary page 1.

## Most influential descendants
- K181241: KLS Martin Individual Patient Solutions (IPS) Planning System (2018), 12 descendants of its own
- K133907: VSP System (2014), 8 descendants of its own
- K182789: KLS Martin Individual Patient Solutions (IPS) Planning System (2019), 7 descendants of its own
- K192282: MedCAD® AccuPlan® System (2020), 3 descendants of its own
- K192192: VSP System (2020), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K120956
Methodology: https://510kreport.com/methodology