# K060950: 3MATIC

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: May 18, 2006 after 42 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.
31 later devices descend from it; 2 cite it directly.
0 of 36 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.
- (no number) Etkon ES-1: named in the summary without a submission number

## Most influential descendants
- K120956: VSP System (2012), 28 descendants of its own
- K181241: KLS Martin Individual Patient Solutions (IPS) Planning System (2018), 12 descendants of its own
- K133907: VSP System (2014), 8 descendants of its own
- K182789: KLS Martin Individual Patient Solutions (IPS) Planning System (2019), 7 descendants of its own
- K192282: MedCAD® AccuPlan® System (2020), 3 descendants of its own

## Indications for use
Materialise's 3Matic is intended for use as software for computer assisted design and manufacturing of medical exo- and endo-prostheses, patient specific medical and dental/orthodontic accessories and dental restorations.

Source page: https://510kreport.com/device/K060950
Methodology: https://510kreport.com/methodology