# K261826: VSP System (Titanium Palatal Splint)

- Pathway: 510(k) (Traditional)
- Applicant: 3D Systems, Inc.
- Decided: Jun 3, 2026 after 2 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: 8 generations back to K924630 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210347: VSP System, 3D Systems (2021) Summary page 5.
- K192192: VSP System, 3D Systems (2020) Summary page 5.

## Indications for use
The 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/K261826
Methodology: https://510kreport.com/methodology