# Materialise NV

- Location (FDA's records): Leuven, BE
- FDA decisions: 62 (1997–2026): 62 510(k) clearances
- Product codes: LLZ (16), JWH (13), QHE (9), KWS (5), HSX (4), PBF (3), JEY (3), MBH (2), DZJ (2), PLW (1), JDI (1), PPT (1)
- 510(k) review time since 2016: median 89 days, against 107 for FDA's reviews in the same codes and years (12 of 30 faster)
- Predicates its devices cite: 93 (74 its own); citations of its devices by later devices: 159 (74 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smith & Nephew, Inc.: 4 (https://510kreport.com/company/smith-nephew)
- Encore Medical L.P.: 3 (https://510kreport.com/company/encore-medical)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Biomet, Inc.: 1 (https://510kreport.com/company/biomet)
- Djo Surgical: 1 (https://510kreport.com/company/djo-surgical)
- Columbia Scientific, Inc.: 1 (https://510kreport.com/company/columbia-scientific)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Pie Medical Imaging BV: 1 (https://510kreport.com/company/pie-medical-imaging)

## Firms that cite its devices most
- Sicat GmbH & Co. KG: 8 (https://510kreport.com/company/sicat)
- Medical Modeling, Inc.: 4 (https://510kreport.com/company/medical-modeling)
- Precision AI Pty, Ltd.: 3 (https://510kreport.com/company/precision-ai)
- Cybermed, Inc.: 3 (https://510kreport.com/company/cybermed)
- Anatomage, Inc.: 2 (https://510kreport.com/company/anatomage)
- Conformis, Inc.: 2 (https://510kreport.com/company/conformis)
- Newclip Technics: 2 (https://510kreport.com/company/newclip-technics)
- Tornier, Inc.: 2 (https://510kreport.com/company/tornier)

## Its most-cited devices
- K033849: Simplant System (2004), cited by 20
- K183105: Mimics Medical (2019), cited by 17
- K073468: Mimics (2008), cited by 9
- K053592: Simplant DR. James (2006), cited by 7
- K102795: Signature Planner; Signature Guides (2011), cited by 7
- K111492: Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments (2011), cited by 7

## Recent decisions
- K260913: CMF Titanium Splints (Oct 9, 2026)
- K260802: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (Jun 9, 2026)
- K251964: Mimics Thoracic Planner (Mar 12, 2026)
- K253308: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (Jan 7, 2026)
- K253793: Materialise TKA Guide System (Jan 6, 2026)
- K251554: Materialise TKA Guide System (Jul 14, 2025)
- K243637: Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (Feb 21, 2025)
- K242813: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (Oct 18, 2024)

Source page: https://510kreport.com/company/materialise