Data / Medical devices / Ukraine / Materialise Ukraine, Rep. office
Materialise Ukraine, Rep. office: FDA-registered device maker in Kyiv Kyyiv, Misto, Ukraine, 47 510(k) clearances
Materialise Ukraine, Rep. office is registered with the FDA (registration 3009555440) in Kyiv Kyyiv, Misto, Ukraine. It lists 18 device types. The FDA files 47 510(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
- 3009555440
- Address
- Raisy Okipnoy str., 8A, Kyiv Kyyiv, Misto, Ukraine, 02002
- Owner or operator
- MATERIALISE N.V. (9029485)
- Roles
- Manufacturer
- First device listed
- April 7, 2008
- Registered through
- 2026
- Brand names listed
- AtlasPlan Shoulder System, BKS Total PSI, Bespoke PSI, Bespoke Patient Specific Instruments, CMF Plastic Models, CMF Titanium Guides, HeartPrint, Lima PSI and more
Devices it lists
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 |
| March 12, 2026 | K251964 | Mimics Thoracic Planner | LLZ | 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 31, 2024 | K223427 | Mimics Enlight CMF | LLZ | 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 |
| February 12, 2024 | K233217 | Mimics Cardiac Planner | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| November 9, 2023 | K233408 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| September 12, 2023 | K231112 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| March 6, 2023 | K230315 | Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| August 17, 2022 | K220452 | Materialise Shoulder SystemTM 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 |
| June 15, 2022 | K213684 | SurgiCase Viewer | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| January 12, 2022 | K212569 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| October 2, 2020 | K202207 | Materialise PKA Guide System | HSX | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| March 20, 2020 | K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner | QHE | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| July 8, 2019 | K190286 | Materialise Glenoid Positioning System | KWS | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| June 5, 2019 | K190874 | Materialise Mimics Enlight | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| March 27, 2019 | K183105 | Mimics Medical | LLZ | 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 |
| July 6, 2018 | K173970 | Materialise PKA Guide System | HSX | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| February 2, 2018 | K173445 | Materialise TKA Guide System | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| November 20, 2017 | K172650 | Materialise PKA Guide System | HSX | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| November 3, 2017 | K172054 | Materialise Glenoid Positioning System | KWS | 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 |
| June 19, 2017 | K170893 | Materialise Glenoid Positioning System | KWS | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| January 18, 2017 | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides | PBF | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| November 7, 2016 | K162273 | Materialise TKA Guide System | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| April 26, 2016 | K153602 | Materialise Glenoid Positioning System | KWS | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| August 10, 2015 | K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| May 22, 2014 | K140027 | ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| April 10, 2014 | K132290 | SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES | PBF | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| April 2, 2014 | K140257 | SIGNATURE PLANNER, SIGNATURE GUIDES | MBH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| February 25, 2014 | K133162 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| September 27, 2013 | K131559 | MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES | KWS | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| December 5, 2012 | K121640 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| April 2, 2012 | K113829 | ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| January 6, 2012 | K112301 | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER | HSX | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| October 13, 2011 | K111492 | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| May 16, 2011 | K110415 | SIGNATURE PLANNER / SIGNATURE GUIDES | HRY | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| February 2, 2011 | K102795 | SIGNATURE PLANNER; SIGNATURE GUIDES | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| February 17, 2010 | K093533 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 | MBH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| November 19, 2009 | K091263 | ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) | JWH | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| April 2, 2008 | K073468 | MIMICS | LLZ | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Shoulder Arthroplasty Implantation System
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Cranial Surgical Planning And Instrument Guides
- All makers of Knee Arthroplasty Implantation System
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.