Data / Medical devices / Belgium / Materialise N.V.
Materialise N.V.: FDA-registered device maker in LEUVEN Vlaams Brabant, Belgium, 58 510(k) clearances
Materialise N.V. is registered with the FDA (registration 3003998208) in LEUVEN Vlaams Brabant, Belgium. It lists 28 device types. The FDA files 58 510(k) clearances under its listings, the newest dated October 9, 2026. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003998208
- Address
- 15 Technologielaan, LEUVEN Vlaams Brabant, Belgium, 3001
- Owner or operator
- MATERIALISE N.V. (9029485)
- Roles
- Manufacturer
- First device listed
- December 11, 2003
- Registered through
- 2027
- Brand names listed
- 3-matic, 3-matic Medical, AnatomyPrint, AtlasPlan Shoulder System, BKS Total PSI, Bespoke PSI, Bespoke Patient Specific Instruments, CMF Plastic Models and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 9, 2026 | K260913 | CMF Titanium Splints | DZJ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| June 9, 2026 | K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| March 12, 2026 | K251964 | Mimics Thoracic Planner | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| January 7, 2026 | K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | PPT | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| January 6, 2026 | K253793 | Materialise TKA Guide System | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| July 14, 2025 | K251554 | Materialise TKA Guide System | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| February 21, 2025 | K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | DZJ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| October 18, 2024 | K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| May 31, 2024 | K223427 | Mimics Enlight CMF | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| May 22, 2024 | K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| February 12, 2024 | K233217 | Mimics Cardiac Planner | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| November 9, 2023 | K233408 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| September 12, 2023 | K231112 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| March 6, 2023 | K230315 | Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| August 17, 2022 | K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| July 5, 2022 | K221337 | Materialise TKA Guide System | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| June 15, 2022 | K213684 | SurgiCase Viewer | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| January 12, 2022 | K212569 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| October 2, 2020 | K202207 | Materialise PKA Guide System | HSX | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| March 20, 2020 | K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| July 8, 2019 | K190286 | Materialise Glenoid Positioning System | KWS | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| June 5, 2019 | K190874 | Materialise Mimics Enlight | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| March 27, 2019 | K183105 | Mimics Medical | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| July 10, 2018 | K173039 | TruMatch CMF Titanium 3D Printed Implant | JEY | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| July 6, 2018 | K173970 | Materialise PKA Guide System | HSX | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| March 21, 2018 | K173619 | Mimics inPrint | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| February 2, 2018 | K173445 | Materialise TKA Guide System | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| November 20, 2017 | K172650 | Materialise PKA Guide System | HSX | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| November 3, 2017 | K172054 | Materialise Glenoid Positioning System | KWS | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| October 18, 2017 | K171068 | OrthoView 7.2 | LLZ | Substantially Equivalent | Meridian Technique, Ltd. | accessdata.fda.gov |
| August 8, 2017 | K170272 | TruMatch CMF Titanium 3D Printed Implant System | JEY | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| June 19, 2017 | K170893 | Materialise Glenoid Positioning System | KWS | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| May 11, 2017 | K170419 | SurgiCase Viewer | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| January 18, 2017 | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | PBF | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| November 7, 2016 | K162273 | Materialise TKA Guide System | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| April 26, 2016 | K153602 | Materialise Glenoid Positioning System | KWS | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| August 10, 2015 | K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| May 22, 2014 | K140027 | ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| April 10, 2014 | K132290 | SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES | PBF | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| April 2, 2014 | K140257 | SIGNATURE PLANNER, SIGNATURE GUIDES | MBH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| February 25, 2014 | K133162 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| September 27, 2013 | K131559 | MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES | KWS | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| December 5, 2012 | K121640 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| July 20, 2012 | K112389 | SURGICASE CONNECT, SURGICASE GUIDE | PBF | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| June 15, 2012 | K111863 | SIGNATURE PLANNER,SIGNATURE GUIDES | JDI | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| April 27, 2012 | K113599 | SURGICASE CONNECT | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| April 2, 2012 | K113829 | ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| March 27, 2012 | K111558 | SURGICASE GUIDE | HAW | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| January 6, 2012 | K112301 | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER | HSX | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| October 13, 2011 | K111492 | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| September 26, 2011 | K111641 | SURGICASE ORTHOGNATHIC SOFTWARE WIZARD | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| May 16, 2011 | K110415 | SIGNATURE PLANNER / SIGNATURE GUIDES | HRY | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| March 18, 2011 | K103136 | SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE | JEY | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| February 2, 2011 | K102795 | SIGNATURE PLANNER; SIGNATURE GUIDES | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| February 17, 2010 | K093533 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 | MBH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| November 19, 2009 | K091263 | ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| April 2, 2008 | K073468 | MIMICS | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| May 18, 2006 | K060950 | 3MATIC | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 19, 2023 | 92732 | Class II | Completed | ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101 | Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request | accessdata.fda.gov |
| April 26, 2023 | 92621 | Class II | Completed | MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR | The wrong tibia guide was included intended for a different patient case. | accessdata.fda.gov |
| July 17, 2020 | 86113 | Class II | Terminated | Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing | The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side. | accessdata.fda.gov |
| February 3, 2020 | 85080 | Class II | Terminated | TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 | Custom surgical kits contain a plate different than indicated by the package labeling. | accessdata.fda.gov |
| September 23, 2015 | 72425 | Class II | Terminated | Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System. | Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed. | accessdata.fda.gov |
| February 4, 2015 | 70664 | Class II | Terminated | Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide durin | Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- All makers of Knee Arthroplasty Implantation System
- All makers of Shoulder Arthroplasty Implantation System
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.