Materialise NV
Medical device manufacturer in Leuven, BE.
61510(k) clearances
0PMA approvals
0recalls
Device types
- LLZ System, Image Processing, Radiological 16
- JWH Prosthesis, Knee, Patellofemorotibial… 13
- QHE Shoulder Arthroplasty Implantation System 9
- KWS Prosthesis, Shoulder, Semi-Constrained… 5
- HSX Prosthesis, Knee, Femorotibial… 4
- JEY Plate, Bone 3
- PBF Orthopaedic Surgical Planning And… 3
- MBH Prosthesis, Knee, Patello/Femorotibial… 2
- HRY Prosthesis, Knee, Femorotibial… 1
- HAW Neurological Stereotaxic Instrument 1
- JDI Prosthesis, Hip, Semi-Constrained… 1
- PLW Acetabular Cup Orientation System 1
- DZJ Driver, Wire, And Bone Drill, Manual 1
- PPT Cranial Surgical Planning And Instrument… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Traditional | 06/09/2026SE |
| K251964 | Mimics Thoracic PlannerLLZ · Traditional | 03/12/2026SE |
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…PPT · Special | 01/07/2026SE |
| K253793 | Materialise TKA Guide SystemJWH · Special | 01/06/2026SE |
| K251554 | Materialise TKA Guide SystemJWH · Traditional | 07/14/2025SE |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional | 02/21/2025SE |
| K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 10/18/2024SE |
| K223427 | Mimics Enlight CMFLLZ · Traditional | 05/31/2024SE |
| K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 05/22/2024SE |
| K233217 | Mimics Cardiac PlannerLLZ · Traditional | 02/12/2024SE |
| K233408 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Special | 11/09/2023SE |
| K231112 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Traditional | 09/12/2023SE |
| K230315 | Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder…QHE · Special | 03/06/2023SE |
| K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder…QHE · Traditional | 08/17/2022SE |
| K221337 | Materialise TKA Guide SystemJWH · Traditional | 07/05/2022SE |
| K213684 | SurgiCase ViewerLLZ · Traditional | 06/15/2022SE |
| K212569 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder…QHE · Traditional | 01/12/2022SE |
| K202207 | Materialise PKA Guide SystemHSX · Traditional | 10/02/2020SE |
| K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner…QHE · Traditional | 03/20/2020SE |
| K190286 | Materialise Glenoid Positioning SystemKWS · Traditional | 07/08/2019SE |
| K190874 | Materialise Mimics EnlightLLZ · Traditional | 06/05/2019SE |
| K183105 | Mimics MedicalLLZ · Traditional | 03/27/2019SE |
| K173039 | TruMatch CMF Titanium 3D Printed ImplantJEY · Traditional | 07/10/2018SE |
| K173970 | Materialise PKA Guide SystemHSX · Traditional | 07/06/2018SE |
| K173619 | Mimics inPrintLLZ · Traditional | 03/21/2018SE |
| K173445 | Materialise TKA Guide SystemJWH · Traditional | 02/02/2018SE |
| K172650 | Materialise PKA Guide SystemHSX · Traditional | 11/20/2017SE |
| K172054 | Materialise Glenoid Positioning SystemKWS · Traditional | 11/03/2017SE |
| K170272 | TruMatch CMF Titanium 3D Printed Implant SystemJEY · Traditional | 08/08/2017SE |
| K170893 | Materialise Glenoid Positioning SystemKWS · Traditional | 06/19/2017SE |
| K170419 | SurgiCase ViewerLLZ · Traditional | 05/11/2017SE |
| K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesPBF · Traditional | 01/18/2017SE |
| K162273 | Materialise TKA Guide SystemJWH · Traditional | 11/07/2016SE |
| K153602 | Materialise Glenoid Positioning SystemKWS · Traditional | 04/26/2016SE |
| K150780 | Acetabular Cup Orientation SystemPLW · Traditional | 10/27/2015SE |
| K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesJWH · Traditional | 08/10/2015SE |
| K140027 | Zimmer Patient Specific Instruments/ System/PlannerJWH · Traditional | 05/22/2014SE |
| K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase GuidesPBF · Traditional | 04/10/2014SE |
| K140257 | Signature Planner, Signature GuidesMBH · Traditional | 04/02/2014SE |
| K133162 | Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer…JWH · Traditional | 02/25/2014SE |
| K131559 | Match Point System(Tm), Surgicase Connect, Match Point System(Tm) GuidesKWS · Traditional | 09/27/2013SE |
| K121640 | Zimmer Patient Specific Instruments SystemJWH · Traditional | 12/05/2012SE |
| K112389 | Surgicase Connect, Surgicase GuidePBF · Traditional | 07/20/2012SE |
| K111863 | Signature Planner,Signature GuidesJDI · Traditional | 06/15/2012SE |
| K113599 | Surgicase ConnectLLZ · Traditional | 04/27/2012SE |
| K113829 | Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments Zimmer…JWH · Traditional | 04/02/2012SE |
| K111558 | Surgicase GuideHAW · Traditional | 03/27/2012SE |
| K112301 | Zimmer Patient Specific Instruments PlannerHSX · Traditional | 01/06/2012SE |
| K111492 | Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific InstrumentsJWH · Traditional | 10/13/2011SE |
| K111641 | Surgicase Orthognathic Software WizardLLZ · Traditional | 09/26/2011SE |
| K110415 | Signature Planner / Signature GuidesHRY · Traditional | 05/16/2011SE |
| K103136 | Surgicase CMF, Surgicase Connect, Surgicase GuideJEY · Traditional | 03/18/2011SE |
| K102795 | Signature Planner; Signature GuidesJWH · Traditional | 02/02/2011SE |
| K093533 | Zimmer Patient Specific Instruments System, Version 2.0MBH · Traditional | 02/17/2010SE |
| K091263 | Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model…JWH · Traditional | 11/19/2009SE |
| K073449 | SurgicaseLLZ · Traditional | 04/16/2008SE |
| K073468 | MimicsLLZ · Traditional | 04/02/2008SE |
| K060950 | 3MATICLLZ · Traditional | 05/18/2006SE |
| K053592 | Simplant Dr. JamesLLZ · Special | 02/08/2006SE |
| K033849 | Simplant SystemLLZ · Traditional | 05/25/2004SE |
| K970617 | Ct-Modeller SystemLLZ · Traditional | 04/21/1997SE |