# K220366: EmbedMed

- Pathway: 510(k) (Traditional)
- Applicant: 3D Lifeprints UK, Ltd.
- Decided: Sep 30, 2022 after 234 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)
- K201353: CenterMed Patient Matched Assisted Surgical Planning (ASP) System, Centermed, Inc. (2021) Summary page 4.

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

Source page: https://510kreport.com/device/K220366
Methodology: https://510kreport.com/methodology