# K231520: tmCMF Solution

- Pathway: 510(k) (Traditional)
- Applicant: Techmah Cmf
- Decided: Oct 2, 2023 after 130 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)
- K192282: MedCAD® AccuPlan® System, Medcad (2020) Summary page 5.

## Most influential descendants
- K233874: tmCMF Solution (2024), 0 descendants of its own

## Indications for use
The tmCMF Solution 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 tmCMF Solution, and the result is an output data file that 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, and dental splints for use in maxillofacial and mandibular surgery. The surgical guides and dental splints are intended to be used for the maxillofacial and mandibular bone in maxillofacial and mandibular surgery. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating surgical treatment options.

Source page: https://510kreport.com/device/K231520
Methodology: https://510kreport.com/methodology