# K222577: TECHFIT Diagnostic Models

- Pathway: 510(k) (Traditional)
- Applicant: Techfit Digital Surgery, Inc.
- Decided: Jan 6, 2023 after 134 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924630 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183105: Mimics Medical, Materialise NV (2019) Summary page 4.

## Indications for use
The TECHFIT Diagnostic Models are patient-specific devices intended to be used as a pre-operative planning tool for treatment in the field of maxillofacial surgery. The input data file (DICOM imaging information from a medical scanner file) is processed by commercial off-the-shelf software, and the result is an output data file that may then be provided as digital models or used as input to produce physical anatomic models using additive manufacturing. The physical replica can be used for diagnostic purposes in the field of, maxillofacial applications. TECHFIT Diagnostic Models should be used in conjunction with other diagnostic tools and expert clinical judgment. TECHFIT Diagnostic Models are not intended to enter the operating room

Source page: https://510kreport.com/device/K222577
Methodology: https://510kreport.com/methodology