# K033849: Simplant System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: May 25, 2004 after 166 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: 2 generations back to K924630 (1993). 3 ancestors in all.
379 later devices descend from it; 20 cite it directly.
0 of 383 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924810: Sim/Plant, Columbia Scientific, Inc. (1993) Summary page 1.
- K970617: CT-Modeller System, Materialise NV (1997) Summary page 1.

## Most influential descendants
- K073449: Surgicase (2008), 143 descendants of its own
- K073468: Mimics (2008), 141 descendants of its own
- K102795: Signature Planner; Signature Guides (2011), 99 descendants of its own
- K111863: Signature Planner,Signature Guides (2012), 71 descendants of its own
- K053592: Simplant DR. James (2006), 68 descendants of its own

## Indications for use
The SimPlant system is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is indicated 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 scanner. It is also indicated for use as a planning and simulation software for dental implant placement and surgical treatment.

Source page: https://510kreport.com/device/K033849
Methodology: https://510kreport.com/methodology