# K233874: tmCMF Solution

- Pathway: 510(k) (Traditional)
- Applicant: Techmah Cmf
- Decided: Jul 11, 2024 after 217 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231520: tmCMF Solution, Techmah Cmf (2023) Summary page 5.
- K173039: TruMatch CMF Titanium 3D Printed Implant, Materialise NV (2018) Summary page 6.
- K170272: TruMatch CMF Titanium 3D Printed Implant System, Materialise NV (2017) Summary page 6.

## 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 manufacturing portion of the system that produces physical outputs, including anatomical models, surgical guides, dental splints, and implants for use in maxillofacial, midface, and mandibular surgery. Implants are intended for bone fixation and reconstruction, restoration of bone defects, and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface, mandible, and chin in adolescents (greater than 12 to 21 years of age) and adults. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating virtual surgical treatment options.

Source page: https://510kreport.com/device/K233874
Methodology: https://510kreport.com/methodology