# K151285: VSP Cranial System

- Pathway: 510(k) (Traditional)
- Applicant: 3D Systems, Inc.
- Decided: Sep 23, 2016 after 498 days
- Product code: PPT (Cranial Surgical Planning And Instrument Guides)
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924630 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133907: VSP System, Medical Modeling, Inc. (2014) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K151285
Methodology: https://510kreport.com/methodology