Data / Medical devices / Colombia / Materialise Colombia S.A.S

Materialise Colombia S.A.S: FDA-registered device maker in Medellin Antioquia, Colombia, 13 510(k) clearances

Name: Materialise Colombia S.A.S FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Materialise Colombia S.A.S is registered with the FDA (registration 3011724582) in Medellin Antioquia, Colombia. It lists 13 device types. The FDA files 13 510(k) clearances under its listings, the newest dated June 9, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011724582
Address: Calle 29, 41-105, Loma San Julian Edificio Soho, interior 401, Medellin Antioquia, Colombia, 050021
Owner or operator: MATERIALISE N.V. (9029485)
Roles: Manufacturer
First device listed: December 11, 2003
Registered through: 2026
Brand names listed: AnatomyPrint, AtlasPlan Shoulder System, BKS Total PSI, CMF Plastic Models, CMF Titanium Guides, HeartPrint, Lima Personalized Surgical Instruments, Match Point System and more

Devices it lists

Device	Product code	Class	Role	Source
Cranial Surgical Planning And Instrument Guides	PPT	2	Manufacturer	accessdata.fda.gov
Driver, Wire, And Bone Drill, Manual	DZJ	2	Manufacturer	accessdata.fda.gov
Knee Arthroplasty Implantation System	OOG	2	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Plate, Bone	JEY	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2	Manufacturer	accessdata.fda.gov
Shoulder Arthroplasty Implantation System	QHE	2	Manufacturer	accessdata.fda.gov
Shoulder Prosthesis, Reverse Configuration	PHX	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
Template	HWT	1	Manufacturer	accessdata.fda.gov

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
June 9, 2026	K260802	Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner	QHE	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 22, 2024	K241143	Materialise Shoulder System, 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
July 10, 2018	K173039	TruMatch CMF Titanium 3D Printed Implant	JEY	Substantially Equivalent	Materialise NV	accessdata.fda.gov
August 8, 2017	K170272	TruMatch CMF Titanium 3D Printed Implant System	JEY	Substantially Equivalent	Materialise NV	accessdata.fda.gov
March 27, 2012	K111558	SURGICASE GUIDE	HAW	Substantially Equivalent	Materialise NV	accessdata.fda.gov
September 26, 2011	K111641	SURGICASE ORTHOGNATHIC SOFTWARE WIZARD	LLZ	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

Compare with other makers

Updated June 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.