# K193499: DigiGuide System

- Pathway: 510(k) (Traditional)
- Applicant: Protomed, Inc.
- Decided: Nov 4, 2020 after 323 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: 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 ProtoMED DigiGuide 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 DigiGuide System and the result is an output data file that is used as the input to a rapid prototyping portion of the system that produces physical outputs including templates for use in maxillofacial surgery. The DigiGuide System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

Source page: https://510kreport.com/device/K193499
Methodology: https://510kreport.com/methodology