# K212570: OsteoPlan System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed, LLC
- Decided: Feb 11, 2022 after 179 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)
- K133907: VSP System, Medical Modeling, Inc. (2014) Summary page 4.
- K120956: VSP System, Medical Modeling, Inc. (2012) Summary page 4.

## Most influential descendants
- K223427: Mimics Enlight CMF (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K212570
Methodology: https://510kreport.com/methodology