# K230276: TECHFIT DISRP® System

- Pathway: 510(k) (Traditional)
- Applicant: Techfit Digital Surgery
- Decided: Jun 23, 2023 after 142 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: 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)
- K182789: KLS Martin Individual Patient Solutions (IPS) Planning System, KLS-Martin L.P. (2019) Summary page 5.
- K200810: IPS CaseDesigner, Nobel Biocare AB (2020) Summary page 5.

## Indications for use
TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) 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 DISRP System 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 surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options. The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.

Source page: https://510kreport.com/device/K230276
Methodology: https://510kreport.com/methodology