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Data / Medical devices / Malaysia / Materialise Sdn Bhd

Materialise Sdn Bhd: FDA-registered device maker in Petaling Jaya Selangor, Malaysia, 45 510(k) clearances

Materialise Sdn Bhd is registered with the FDA (registration 3009555447) in Petaling Jaya Selangor, Malaysia. It lists 18 device types. The FDA files 45 510(k) clearances under its listings, the newest dated June 9, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Materialise Sdn Bhd
FDA registration number
3009555447
Address
Unit 5-01, Menara Obyu, No. 4, Jalan PJU 8/8A Damansara Perdana, Petaling Jaya Selangor, Malaysia, 47820
Owner or operator
MATERIALISE N.V. (9029485)
Roles
Manufacturer
First device listed
December 11, 2003
Registered through
2026
Brand names listed
3-matic, 3-matic Medical, AtlasPlan Shoulder System, BKS Total PSI, Bespoke PSI, Bespoke Patient Specific Instruments, CMF Plastic Models, CMF Titanium Guides and more

Devices it lists

DeviceProduct codeClassRoleSource
Cranial Surgical Planning And Instrument GuidesPPT2Manufactureraccessdata.fda.gov
DistometerHMM1Manufactureraccessdata.fda.gov
Driver, Wire, And Bone Drill, ManualDZJ2Manufactureraccessdata.fda.gov
Knee Arthroplasty Implantation SystemOOG2Manufactureraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Manufactureraccessdata.fda.gov
Oral Airway AssistPHS1Manufactureraccessdata.fda.gov
Orthopaedic Surgical Planning And Instrument GuidesPBF2Manufactureraccessdata.fda.gov
Plate, BoneJEY2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerHSX2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/PolymerMBV2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOIY2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Manufactureraccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Manufactureraccessdata.fda.gov
Shoulder Arthroplasty Implantation SystemQHE2Manufactureraccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 9, 2026K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially EquivalentMaterialise NVaccessdata.fda.gov
March 12, 2026K251964Mimics Thoracic PlannerLLZSubstantially EquivalentMaterialise NVaccessdata.fda.gov
January 7, 2026K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsPPTSubstantially EquivalentMaterialise NVaccessdata.fda.gov
January 6, 2026K253793Materialise TKA Guide SystemJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
July 14, 2025K251554Materialise TKA Guide SystemJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
February 21, 2025K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJSubstantially EquivalentMaterialise NVaccessdata.fda.gov
October 18, 2024K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially EquivalentMaterialise NVaccessdata.fda.gov
May 31, 2024K223427Mimics Enlight CMFLLZSubstantially EquivalentMaterialise NVaccessdata.fda.gov
May 22, 2024K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially EquivalentMaterialise NVaccessdata.fda.gov
February 12, 2024K233217Mimics Cardiac PlannerLLZSubstantially EquivalentMaterialise NVaccessdata.fda.gov
November 9, 2023K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially EquivalentMaterialise NVaccessdata.fda.gov
September 12, 2023K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially EquivalentMaterialise NVaccessdata.fda.gov
March 6, 2023K230315Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHESubstantially EquivalentMaterialise NVaccessdata.fda.gov
August 17, 2022K220452Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHESubstantially EquivalentMaterialise NVaccessdata.fda.gov
July 5, 2022K221337Materialise TKA Guide SystemJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
January 12, 2022K212569Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHESubstantially EquivalentMaterialise NVaccessdata.fda.gov
October 2, 2020K202207Materialise PKA Guide SystemHSXSubstantially EquivalentMaterialise NVaccessdata.fda.gov
March 20, 2020K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerQHESubstantially EquivalentMaterialise NVaccessdata.fda.gov
July 8, 2019K190286Materialise Glenoid Positioning SystemKWSSubstantially EquivalentMaterialise NVaccessdata.fda.gov
July 10, 2018K173039TruMatch CMF Titanium 3D Printed ImplantJEYSubstantially EquivalentMaterialise NVaccessdata.fda.gov
July 6, 2018K173970Materialise PKA Guide SystemHSXSubstantially EquivalentMaterialise NVaccessdata.fda.gov
February 2, 2018K173445Materialise TKA Guide SystemJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
November 20, 2017K172650Materialise PKA Guide SystemHSXSubstantially EquivalentMaterialise NVaccessdata.fda.gov
November 3, 2017K172054Materialise Glenoid Positioning SystemKWSSubstantially EquivalentMaterialise NVaccessdata.fda.gov
August 8, 2017K170272TruMatch CMF Titanium 3D Printed Implant SystemJEYSubstantially EquivalentMaterialise NVaccessdata.fda.gov
June 19, 2017K170893Materialise Glenoid Positioning SystemKWSSubstantially EquivalentMaterialise NVaccessdata.fda.gov
November 7, 2016K162273Materialise TKA Guide SystemJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
April 26, 2016K153602Materialise Glenoid Positioning SystemKWSSubstantially EquivalentMaterialise NVaccessdata.fda.gov
August 10, 2015K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
May 22, 2014K140027ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNERJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
April 2, 2014K140257SIGNATURE PLANNER, SIGNATURE GUIDESMBHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
February 25, 2014K133162ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLAJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
December 5, 2012K121640ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEMJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
July 20, 2012K112389SURGICASE CONNECT, SURGICASE GUIDEPBFSubstantially EquivalentMaterialise NVaccessdata.fda.gov
April 2, 2012K113829ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNEJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
March 27, 2012K111558SURGICASE GUIDEHAWSubstantially EquivalentMaterialise NVaccessdata.fda.gov
January 6, 2012K112301ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNERHSXSubstantially EquivalentMaterialise NVaccessdata.fda.gov
October 13, 2011K111492ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTSJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
September 26, 2011K111641SURGICASE ORTHOGNATHIC SOFTWARE WIZARDLLZSubstantially EquivalentMaterialise NVaccessdata.fda.gov
May 16, 2011K110415SIGNATURE PLANNER / SIGNATURE GUIDESHRYSubstantially EquivalentMaterialise NVaccessdata.fda.gov
March 18, 2011K103136SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDEJEYSubstantially EquivalentMaterialise NVaccessdata.fda.gov
February 2, 2011K102795SIGNATURE PLANNER; SIGNATURE GUIDESJWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
February 17, 2010K093533ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0MBHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
November 19, 2009K091263ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)JWHSubstantially EquivalentMaterialise NVaccessdata.fda.gov
May 18, 2006K0609503MATICLLZSubstantially EquivalentMaterialise NVaccessdata.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.