# K161634: IPS CaseDesigner

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Nov 10, 2016 after 149 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). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052424: Maxilim, Medicim NV (2006) Summary page 4.
- K111641: Surgicase Orthognathic Software Wizard, Materialise NV (2011) Summary page 4.

## Most influential descendants
- K200810: IPS CaseDesigner (2020), 1 descendant 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
IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of cranio-maxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.

Source page: https://510kreport.com/device/K161634
Methodology: https://510kreport.com/methodology