# K170419: SurgiCase Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: May 11, 2017 after 87 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: 6 generations back to K924630 (1993). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113599: Surgicase Connect, Materialise NV (2012) Summary page 4.
- K132290: Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides, Materialise NV (2014) Summary page 5.

## Most influential descendants
- 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
SurgiCase Viewer is intended to be used as a software interface to assist in visualization and communication of treatment options.

Source page: https://510kreport.com/device/K170419
Methodology: https://510kreport.com/methodology