# K221943: EmbedMed

- Pathway: 510(k) (Traditional)
- Applicant: 3D Lifeprints UK, Ltd.
- Decided: Feb 1, 2023 after 211 days
- Product code: PBF (Orthopaedic Surgical Planning And Instrument Guides)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K190044 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212237: 3D-Cut, 3D-Side S.A. (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 the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies, including the resection of bone tumors, for the appendicular skeleton. EmbedMed is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

Source page: https://510kreport.com/device/K221943
Methodology: https://510kreport.com/methodology