# K133907: VSP System

- Pathway: 510(k) (Special)
- Applicant: Medical Modeling, Inc.
- Decided: Jan 22, 2014 after 30 days
- Product code: DZJ (Driver, Wire, And Bone Drill, Manual)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924630 (1993). 10 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120956: VSP System, Medical Modeling, Inc. (2012) Summary page 1.

## Most influential descendants
- K192192: VSP System (2020), 3 descendants of its own
- K212570: OsteoPlan System (2022), 1 descendant of its own
- K210347: VSP System (2021), 1 descendant of its own
- K261826: VSP System (Titanium Palatal Splint) (2026), 0 descendants of its own
- K223427: Mimics Enlight CMF (2024), 0 descendants of its own

## Recalls of this device
- May 17, 2022 · Class II · Z-1510-2022: Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

## Indications for use
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.

Source page: https://510kreport.com/device/K133907
Methodology: https://510kreport.com/methodology