Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011724582

FEI Number

3011724582

Entity Name

Materialise Colombia S.A.S

City/State/Country

Medellin Antioquia, CO

Establishment Address

Calle 29, 41-105, Loma San Julian, Edificio Soho, interior 401, Medellin Antioquia 050021, CO

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

K173039

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 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 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 Signature Guides Materialise TKA Guides Zimmer Patient Specific Instruments Planner Materialise SurgiCase Knee Planner BKS Total PSI Lima Personalized Surgical Instruments Materialise TKA Guides and Models SurgiCase Knee Planner Materialise Knee Guides Materialise SurgiCase Knee Module Signature Planner Materialise TKA Guide System Zimmer Biomet Patient Specific Instruments Zimmer Patient Specific Instruments Materialise Knee Guide System Materialise TKA Guide Planner Materialise Knee Platform Materialise Knee Planner 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 ProPlan CMF Models CMF Plastic Models Materialise Personalized Guides and Models for Craniomaxillofacial Surgery TRUMATCH CMF Titanium 3D Printed Guides CMF Titanium Guides Materialise Personalized Guides and Models for Craniomaxillofacial Surgery TRUMATCH CMF Titanium 3D Printed Guides ProPlan CMF Models CMF Titanium Guides CMF Plastic Models ProPlan CMF SurgiCase CMF SurgiCase SurgiCase CMF Guides ProPlan CMF Guides SurgiCase Models ProPlan CMF (Orthognathic Splints) ProPlan CMF Models SurgiCase CMF Models HeartPrint AnatomyPrint 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 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

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
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
JEY	Plate, Bone	Dental	Class 2	872.4760	2017-08-21
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2022-07-26
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2022-07-26
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2022-07-26
OOG	Knee Arthroplasty Implantation System	Orthopedic	Class 2	888.3560	2022-07-26
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
PPT	Cranial Surgical Planning And Instrument Guides	Neurology	Class 2	882.4310	2026-01-30
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-02-26
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2025-02-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-12-21
JEY	Plate, Bone	Dental	Class 2	872.4760	2011-03-25
HWT	Template	Orthopedic	Class 1	888.4800	2003-12-11
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
JEY	Plate, Bone	Dental	Class 2	872.4760	2018-09-07

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
3003998208	MATERIALISE N.V.	LEUVEN Vlaams Brabant, BE
3009555440	Materialise Ukraine, Rep. office	Kyiv Kyyiv, Misto, UA
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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3004153240	ConforMIS, Inc.	Wilmington, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011724582. Last updated year: 2026. Please use registration number 3011724582 when referencing this establishment in official correspondence.