# K113599: Surgicase Connect

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Apr 27, 2012 after 144 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.
4 later devices descend from it; 1 cites it directly.
0 of 10 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 2.

## Most influential descendants
- K170419: SurgiCase Viewer (2017), 3 descendants of its own
- K213684: SurgiCase Viewer (2022), 1 descendant of its own
- K260206: SkeletonPlanner (2026), 0 descendants of its own
- K260116: CustoMED Viewer (2026), 0 descendants of its own

## Indications for use
The SurgiCase system is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options. SurgiCase Connect for iPad is a component of the SurgiCase system and is intended to be used as a software interface to assist in pre-operative planning by simulation / evaluation of surgical treatment options.

Source page: https://510kreport.com/device/K113599
Methodology: https://510kreport.com/methodology