# K220648: OMF ASP System

- Pathway: 510(k) (Traditional)
- Applicant: Vha Dean
- Decided: Aug 11, 2022 after 157 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: 7 generations back to K924630 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The OMF ASP 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 OMF ASP System, and the result is an output data file that may then be provided as digital models or used as input to an additive manufacturing portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The OMF ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

Source page: https://510kreport.com/device/K220648
Methodology: https://510kreport.com/methodology