# K111641: Surgicase Orthognathic Software Wizard

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Sep 26, 2011 after 105 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: 4 generations back to K924630 (1993). 5 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073449: Surgicase, Materialise NV (2008) Summary page 1.

## Most influential descendants
- K161634: IPS CaseDesigner (2016), 3 descendants of its own
- K200810: IPS CaseDesigner (2020), 1 descendant of its own
- K223427: Mimics Enlight CMF (2024), 0 descendants of its own
- K230276: TECHFIT DISRP® System (2023), 0 descendants of its own
- K212981: MirrorMe3D Modeling System (2022), 0 descendants of its own

## Indications for use
SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.

Source page: https://510kreport.com/device/K111641
Methodology: https://510kreport.com/methodology