# K201353: CenterMed Patient Matched Assisted Surgical Planning (ASP) System

- Pathway: 510(k) (Traditional)
- Applicant: Centermed, Inc.
- Decided: Jun 28, 2021 after 403 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.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181241: KLS Martin Individual Patient Solutions (IPS) Planning System, KLS-Martin L.P. (2018) Summary page 4.

## Most influential descendants
- K220366: EmbedMed (2022), 0 descendants of its own

## Indications for use
CenterMed Patient Matched Assisted Surgical Planning (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 ASP system and the result is an output data file. This file 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, surgical guides, surgical splints and surgical planning case reports for use in maxillofacial surgery. CenterMed Patient Matched ASP System is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

Source page: https://510kreport.com/device/K201353
Methodology: https://510kreport.com/methodology