# K073449: Surgicase

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Apr 16, 2008 after 128 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: 3 generations back to K924630 (1993). 4 ancestors in all.
143 later devices descend from it; 7 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033849: Simplant System, Materialise NV (2004) Summary page 1.

## Most influential descendants
- K102795: Signature Planner; Signature Guides (2011), 99 descendants of its own
- K111863: Signature Planner,Signature Guides (2012), 71 descendants of its own
- K121640: Zimmer Patient Specific Instruments System (2012), 60 descendants of its own
- K112389: Surgicase Connect, Surgicase Guide (2012), 59 descendants of its own
- K131129: Cas Psi Shoulder (2013), 39 descendants of its own

## Indications for use
The Materialise SuurgiCase' 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 I evaluating implant placement and surgical treatment options.

Source page: https://510kreport.com/device/K073449
Methodology: https://510kreport.com/methodology