Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003998208

FEI Number

3003998208

Entity Name

MATERIALISE N.V.

City/State/Country

LEUVEN Vlaams Brabant, BE

Establishment Address

15 TECHNOLOGIELAAN, LEUVEN Vlaams Brabant 3001, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MATERIALISE N.V. (Owner Number: 9029485)

Owner / Operator Contact Address

Technologielaan 15, --, Leuven, BE-NOTA 3001, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BKS Total PSI Signature Guides Materialise TKA Guide System Materialise TKA Guides and Models Zimmer Biomet Patient Specific Instruments Materialise TKA Guide Planner SurgiCase Knee Planner Materialise Knee Guide System Zimmer Patient Specific Instruments Materialise SurgiCase Knee Planner Materialise Knee Guides Materialise SurgiCase Knee Module Materialise TKA Guides Zimmer Patient Specific Instruments Planner Materialise Knee Planner Lima Personalized Surgical Instruments Materialise Knee Platform Signature Planner Mimics Viewer XR Viewer SurgiCase Viewer Mimics Enlight Materialise Mimics Enlight OrthoView SurgiCase Shoulder Planner Lima Personalized Surgical Instruments Match Point System Materialise Glenoid Positioning System guides Materialise Shoulder Planner Match Point System guides Materialise SurgiCase Planner Materialise Glenoid Positioning System TruMatch CMF Ti 3D-Printed Plates TruMatch CMF Ti 3D-Printed Implants TruMatch CMF Ti 3D-Printed Surgical Guides TruMatch CMF Titanium 3D Printed Implant System Materialise Shoulder System Materialise Shoulder Guide and Models Materialise Shoulder Planner Materialise SurgiCase Planner Match Point System AtlasPlan Shoulder System TruMatch Personalized Solutions Shoulder Guide Match Point System guides Lima Personalized Surgical Instruments SurgiCase Shoulder Planner Materialise Glenoid Positioning System guides SurgiCase Planner Materialise Glenoid Positioning System Mimics Cardiac Planner Materialise TKA Guide System Materialise Knee Guide System Signature Guides Lima Personalized Surgical Instruments SurgiCase Knee Planner Materialise SurgiCase Knee Planner Materialise TKA Guides Materialise Knee Platform Zimmer Patient Specific Instruments Planner Materialise TKA Guides and Models Materialise Knee Guides Materialise Knee Planner Signature Planner BKS Total PSI Materialise TKA Guide Planner Zimmer Biomet Patient Specific Instruments Materialise SurgiCase Knee Module Zimmer Patient Specific Instruments Signature Personalized Patient Care System Signature Planner Signature Guide Materialise SurgiCase Knee Module Materialise SurgiCase Knee Planner Materialise Knee Planner Materialise Knee Guides Materialise PKA Guides Materialise Knee Guide System SurgiCase Knee Planner Materialise PKA Guide planner Materialise Knee Guide planner Materialise Knee Platform Materialise PKA Guide System TruMatch Personalized Solutions Shoulder Guide Materialise Glenoid Positioning System Lima Personalized Surgical Instruments Materialise Shoulder Planner Match Point System Materialise Glenoid Positioning System guides SurgiCase Shoulder Planner Match Point System guides Materialise Shoulder Guide and Models AtlasPlan Shoulder System Materialise SurgiCase Planner Materialise Shoulder System SurgiCase Planner Materialise SurgiCase Knee Module Materialise SurgiCase Knee Planner Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planner Materialise TKA Guides Signature Planner Materialise TKA Guide System Materialise Knee Planner Signature Guides Materialise Knee Guides Materialise Knee Platform Materialise TKA Guide planner SurgiCase Knee Planner Materialise Eyewear Fitting Suite SurgiCase Online Management System Zimmer Patient Specific Instruments Online Management System SurgiCase Transfer SurgiCase OOS SurgiCase Online Signature Online Management System SurgiCase Drive SurgiCase Mobile ProPlan CMF Online Materialise Shoulder Guide and Models TruMatch Personalized Solutions Shoulder Guide Materialise SurgiCase Planner Match Point System Match Point System guides Lima Personalized Surgical Instruments Materialise Glenoid Positioning System guides Materialise Shoulder Planner Materialise Glenoid Positioning System AtlasPlan Shoulder System Materialise Shoulder System SurgiCase Shoulder Planner SurgiCase Planner Materialise TKA Guide System Materialise TKA Guides SurgiCase Knee Planner Materialise SurgiCase Knee Module Materialise Knee Planner Materialise Knee Guides Materialise Knee Guide planner Materialise Knee Platform Bespoke PSI Materialise Knee Guide System Materialise TKA Guide planner Bespoke Patient Specific Instruments Materialise SurgiCase Knee Planner Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planner Zimmer Patient Specific Instruments System SurgiCase Connect SurgiCase Guide SurgiCase Orthopaedics SurgiCase Planner Lima Personalized Surgical Instruments Materialise Glenoid Positioning System guides Match Point System Match Point System guides Materialise Shoulder Planner Materialise Shoulder Guide and Models SurgiCase Shoulder Planner Materialise Glenoid Positioning System TruMatch Personalized Solutions Shoulder Guide AtlasPlan Shoulder System Materialise Shoulder System Materialise SurgiCase Planner SurgiCase Orthopaedics SurgiCase Guide SurgiCase Connect Materialise SurgiCase Planner TruMatch Personalized Solutions Shoulder Guide Materialise Glenoid Positioning System Materialise Shoulder Guide and Models Lima Personalized Surgical Instruments SurgiCase Planner AtlasPlan Shoulder System Materialise Shoulder System Materialise Shoulder Planner Match Point System SurgiCase Shoulder Planner Match Point System guides Materialise Glenoid Positioning System guides Materialise Shoulder Guide and Models Lima Personalized Surgical Instruments Materialise Glenoid Positioning System guides Match Point System guides TruMatch Personalized Solutions Shoulder Guide AtlasPlan Shoulder System SurgiCase Shoulder Planner Materialise Shoulder Planner Materialise SurgiCase Planner Materialise Glenoid Positioning System SurgiCase Planner Materialise Shoulder System Match Point System SurgiCase Viewer Viewer SurgiCase System SurgiCase SurgiCase Connect Lima Personalized Surgical Instruments TruMatch Personalized Solutions Shoulder Guide SurgiCase Planner TruMatch Personalized Solutions Shoulder System Materialise Shoulder Planner Materialise SurgiCase Planner Match Point System Materialise Glenoid Positioning System Match Point System guides Materialise Glenoid Positioning System guides SurgiCase Shoulder Planner Materialise PKA Guides Materialise PKA Guide System Zimmer Patient Specific Instruments Signature Guides SurgiCase Knee Planner Zimmer Biomet Patient Specific Instruments Zimmer Patient Specific Instruments Planner Signature Planner Mimics Thoracic Planner Mimics Medical Mimics inPrint Mimics Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments System Zimmer Patient Specific Instruments Planner Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments System Zimmer Patient Specific Instruments Planner SurgiCase CMF Guides ProPlan CMF Guides Materialise SurgiCase Knee Planner Materialise TKA Guides Lima PSI Materialise Knee Guides Materialise TKA Guide planner Materialise SurgiCase Knee Module Materialise Knee Guide System Materialise Knee Planner Materialise Knee Guide planner SurgiCase Knee Planner Materialise Knee Platform Materialise TKA Guide System TruMatch CMF Titanium 3D Printed Implant System TruMatch CMF Ti 3D-Printed Surgical Guides TruMatch CMF Ti 3D-Printed Plates TruMatch CMF Ti 3D-Printed Implants Signature Personalized Patient Care System Signature Planner Signature Guide Materialise PKA Guides Materialise PKA Models SurgiCase Knee Planner Zimmer Biomet Patient Specific Instruments Materialise PKA Guide System Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments System Zimmer Patient Specific Instruments Planner Mimics Enlight CMF Materialise Mimics Enlight CMF Mimics Medical Mimics Automatic Algorithms Knee CT Mimics Automatic Algorithms CMF CT Mimics Automatic Algorithms Knee MRI Mimics Automatic Algorithms Heart CT Mimics Plugin Segment Thin Bone HeartPrint Mimics Plugin Compare Masks Mimics Plugin RT Plugin Mimics Automatic Algorithms Torso Bones CT Mimics Automatic Algorithms Ankle CT Phits 3-matic 3-matic Medical SignatureTM Planner SignatureTM Guide SignatureTM Personalized Patient Care System Zimmer Patient Specific Instruments Zimmer Patient Specific Instruments Planner Zimmer Patient Specific Instruments System SurgiCase Guide SurgiCase Connect SurgiCase Orthopaedics System Zimmer Patient Specific Instruments Planner Zimmer Patient Specific Instruments System Zimmer Patient Specific Instruments SurgiCase Models ProPlan CMF (Orthognathic Splints) ProPlan CMF Models SurgiCase CMF Models HeartPrint AnatomyPrint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2026-03-03
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2026-03-03
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2026-03-03
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2026-03-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-08-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-07-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-04-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2016-07-06
JEY	Plate, Bone	Dental	Class 2	872.4760	2017-08-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-06-18
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-06-18
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2024-06-18
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-03-13
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2025-09-25
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2025-09-25
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2025-09-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2025-09-25
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2014-04-30
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-04-30
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-04-30
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-04-30
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-04-30
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2017-12-04
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2017-12-04
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-11-30
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-11-30
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2023-11-30
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2018-03-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-03-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2018-03-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-03-26
HMM	Distometer	Ophthalmic	Class 1	886.1190	2023-11-30
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2011-12-20
PHS	Oral Airway Assist	Anesthesiology	Class 1	868.5110	2023-05-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-05-23
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2023-05-23
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2015-08-19
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2015-08-19
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2015-08-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2015-08-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-04-11
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2012-04-11
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2012-04-11
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2012-08-02
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-09-15
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-09-15
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2022-09-15
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2014-04-23
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-09-27
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2023-09-27
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-09-27
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2024-12-03
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2024-12-03
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2024-12-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-06-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-05-22
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-07-17
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2018-07-13
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2018-07-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-03-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-04-07
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2012-12-27
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2012-12-27
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2010-03-03
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2010-03-03
JEY	Plate, Bone	Dental	Class 2	872.4760	2011-03-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-11-28
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2016-11-28
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2016-11-28
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2016-11-28
JEY	Plate, Bone	Dental	Class 2	872.4760	2018-09-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-05-26
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2011-05-26
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2011-05-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2011-05-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2011-05-26
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2020-12-10
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2020-12-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2009-11-25
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2009-11-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-08-29
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2024-08-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-05-28
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2019-01-22
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-05-13
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-05-13
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2020-05-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2003-12-11
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2012-07-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2012-07-06
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2012-07-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2012-07-06
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2012-07-06
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2012-07-06
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2012-07-06
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2012-01-24
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2012-01-24
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2017-02-07
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2014-06-06
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2014-06-06
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2014-06-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-06-06
HWT	Template	Orthopedic	Class 1	888.4800	2003-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

Jenny Jones Business: Materialise USA Email: jenny.jones@materialise.com Phone: (734) 2597017

Related Public Records

Same Entity

MATERIALISE N.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3026963399	Materialise S.A.	Bielany Wroclawskie Dolnoslaskie, PL
3006543248	Materialise Motion N.V.	Paal Limburg, BE
3009555440	Materialise Ukraine, Rep. office	Kyiv Kyyiv, Misto, UA
3011724582	Materialise Colombia S.A.S	Medellin Antioquia, CO
3005718816	Materialise USA, LLC.	Plymouth, MI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25
K153310	Total Joint Orthopedics, Inc.	Klassic Knee System	2015-12-17
K102380	Wrightmedicaltechnologyinc	EVOLUTION MP TOTAL KNEE SYSTEM	2011-01-07
K122985	Aesculap Implant System, Inc.	COLUMBUS REVISION KNEE SYSTEM	2012-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003998208. Last updated year: 2026. Please use registration number 3003998208 when referencing this establishment in official correspondence.