Materialise USA, LLC.

Registration Details

Registration Name: Materialise USA, LLC.
Registration Number: 3005718816
FEI Number: 3005718816
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 44650 Helm Court
City: Plymouth
State: MI
ZIP: 48170
Country: US

Regulatory Submissions

510(k) Number: K111558

Owner / Operator

Firm Name: MATERIALISE N.V.
Operator Number: 9029485
Address: Technologielaan 15, --
City: Leuven
State: BE-NOTA
Postal Code: 3001
Country: BE

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Neurological Stereotaxic Instrument	HAW	Class 2	Neurology	No	2012-04-11
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	Class 2	Orthopedic	No	2019-07-17
Orthopaedic Surgical Planning And Instrument Guides	PBF	Class 2	Orthopedic	No	2017-02-07
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	Class 2	Orthopedic	No	2025-09-25
Knee Arthroplasty Implantation System	OOG	Class 2	Orthopedic	No	2025-09-25
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	Class 2	Orthopedic	No	2025-09-25
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	Class 2	Orthopedic	No	2025-09-25
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	Class 2	Orthopedic	No	2012-01-24
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	Class 2	Orthopedic	No	2018-09-19
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	LWJ	Class 2	Orthopedic	No	2018-09-19
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	Class 2	Orthopedic	No	2018-09-19
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	Class 2	Orthopedic	No	2012-07-06
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	Class 2	Orthopedic	No	2012-07-06
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	Class 2	Orthopedic	No	2012-07-06
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	Class 2	Orthopedic	No	2012-07-06
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	MAY	Class 2	Orthopedic	No	2012-07-06
Shoulder Prosthesis, Reverse Configuration	PHX	Class 2	Orthopedic	No	2022-09-15
Shoulder Arthroplasty Implantation System	QHE	Class 2	Orthopedic	No	2022-09-15
System, Image Processing, Radiological	LLZ	Class 2	Radiology	No	2025-02-26
Driver, Wire, And Bone Drill, Manual	DZJ	Class 2	Dental	No	2025-02-26
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	HRY	Class 2	Orthopedic	No	2011-05-26
Oral Airway Assist	PHS	Class 1	Anesthesiology	No	2023-05-23
Plate, Bone	JEY	Class 2	Dental	No	2017-08-21
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	MBV	Class 2	Orthopedic	No	2014-04-30
Orthosis, Corrective Shoe	KNP	Class 1	Physical Medicine	No	2019-01-22
Cranial Surgical Planning And Instrument Guides	PPT	Class 2	Neurology	No	2026-01-30
Template	HWT	Class 1	Orthopedic	No	2003-12-11

Proprietary Names

SurgiCase CMF Guide ProPlan CMF Guide 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 SurgiCase Guide SurgiCase Connect SurgiCase Orthopaedics System Materialise TKA Guide System Materialise Knee Guide System Signature Guides 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 Zimmer Patient Specific Instruments System Corin Optimized Positioning System (OPS) Femoral Lima PSI Materialise TKA Guide planner Materialise Knee Guide planner Materialise PKA Guides Materialise PKA Guide System SignatureTM Planner SignatureTM Guide SignatureTM Personalized Patient Care System Materialise Shoulder Guide and Models AtlasPlan Shoulder System Materialise Shoulder System Signature Personalized Patient Care System Signature Guide Materialise Personalized Guides and Models for Craniomaxillofacial Surgery TRUMATCH CMF Titanium 3D Printed Guides ProPlan CMF Models CMF Titanium Guides CMF Plastic Models Bespoke PSI Bespoke Patient Specific Instruments 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 MatchPoint System TM Guides MatchPoint System TM SurgiCase Orthopaedics Phits Mimics inPrint Materialise PKA Models SurgiCase Models ProPlan CMF (Orthognathic Splints) SurgiCase CMF Models HeartPrint AnatomyPrint SurgiCase CMF Guides ProPlan CMF Guides Acetabular Guide Trial Acetabulum Materialise PKA Guide planner

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)