510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Materialise N.V.

LEUVEN Vlaams Brabant, BE

MATERIALISE N.V. appears in FDA device records in LEUVEN Vlaams Brabant, BE. FDA records list 61 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
61
PMA records
0
Recall records
7
Registered establishments
2

510(k) clearance history

Showing 50 of 61

FDA records hold 61 510(k) clearances for Materialise N.V. between 1997 and 2026. The busiest year on record is 2012, with 7. The most recent is 2026, with 4.

Clearances by year, as a table
510(k) clearance decisions for Materialise N.V., by decision year
YearClearances
19971
20041
20062
20082
20091
20101
20115
20127
20131
20144
20152
20162
20176
20184
20193
20202
20224
20233
20244
20252
20264
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially Equivalent
K251964Mimics Thoracic PlannerLLZSubstantially Equivalent
K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsPPTSubstantially Equivalent
K253793Materialise TKA Guide SystemJWHSubstantially Equivalent
K251554Materialise TKA Guide SystemJWHSubstantially Equivalent
K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJSubstantially Equivalent
K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially Equivalent
K223427Mimics Enlight CMFLLZSubstantially Equivalent
K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially Equivalent
K233217Mimics Cardiac PlannerLLZSubstantially Equivalent
K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially Equivalent
K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially Equivalent
K230315Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHESubstantially Equivalent
K220452Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHESubstantially Equivalent
K221337Materialise TKA Guide SystemJWHSubstantially Equivalent
K213684SurgiCase ViewerLLZSubstantially Equivalent
K212569Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially Equivalent
K202207Materialise PKA Guide SystemHSXSubstantially Equivalent
K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerQHESubstantially Equivalent
K190286Materialise Glenoid Positioning SystemKWSSubstantially Equivalent
K190874Materialise Mimics EnlightLLZSubstantially Equivalent
K183105Mimics MedicalLLZSubstantially Equivalent
K173039TruMatch CMF Titanium 3D Printed ImplantJEYSubstantially Equivalent
K173970Materialise PKA Guide SystemHSXSubstantially Equivalent
K173619Mimics inPrintLLZSubstantially Equivalent
K173445Materialise TKA Guide SystemJWHSubstantially Equivalent
K172650Materialise PKA Guide SystemHSXSubstantially Equivalent
K172054Materialise Glenoid Positioning SystemKWSSubstantially Equivalent
K170272TruMatch CMF Titanium 3D Printed Implant SystemJEYSubstantially Equivalent
K170893Materialise Glenoid Positioning SystemKWSSubstantially Equivalent
K170419SurgiCase ViewerLLZSubstantially Equivalent
K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesPBFSubstantially Equivalent
K162273Materialise TKA Guide SystemJWHSubstantially Equivalent
K153602Materialise Glenoid Positioning SystemKWSSubstantially Equivalent
K150780Acetabular Cup Orientation SystemPLWSubstantially Equivalent
K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesJWHSubstantially Equivalent
K140027ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNERJWHSubstantially Equivalent
K132290SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDESPBFSubstantially Equivalent
K140257SIGNATURE PLANNER, SIGNATURE GUIDESMBHSubstantially Equivalent
K133162ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLAJWHSubstantially Equivalent
K131559MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDESKWSSubstantially Equivalent
K121640ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEMJWHSubstantially Equivalent
K112389SURGICASE CONNECT, SURGICASE GUIDEPBFSubstantially Equivalent
K111863SIGNATURE PLANNER,SIGNATURE GUIDESJDISubstantially Equivalent
K113599SURGICASE CONNECTLLZSubstantially Equivalent
K113829ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNEJWHSubstantially Equivalent
K111558SURGICASE GUIDEHAWSubstantially Equivalent
K112301ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNERHSXSubstantially Equivalent
K111492ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTSJWHSubstantially Equivalent
K111641SURGICASE ORTHOGNATHIC SOFTWARE WIZARDLLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Materialise N.V., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30039982083003998208MATERIALISE N.V.15 TECHNOLOGIELAAN, LEUVEN Vlaams Brabant 3001 BE2026and 18 more, listed in full below
30269633993026963399Materialise S.A.Belgijska 1, Bielany Wroclawskie Dolnoslaskie 55-040 PL2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2287-2023ProPlan 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: SD900.101Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design requestClass IICompleted
Z-2213-2023MRI 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. Ref: KNM-ZB02-00-01The wrong tibia guide was included intended for a different patient case.Class IICompleted
Z-2886-2020Match 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 anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.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.Class IITerminated
Z-1485-2020TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013Custom surgical kits contain a plate different than indicated by the package labeling.Class IITerminated
Z-1484-2020TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001Custom surgical kits contain a plate different than indicated by the package labeling.Class IITerminated
Z-0162-2016Signature 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.Class IITerminated
Z-1287-2015Signature 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 during the surgical procedure for total and partial knee arthroplasty.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.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain