Data / Medical devices / United States / Materialise USA, LLC.
Materialise USA, LLC.: FDA-registered device maker in Plymouth, MI, United States, 45 510(k) clearances
Materialise USA, LLC. is registered with the FDA (registration 3005718816) in Plymouth, MI, United States. It lists 27 device types. The FDA files 45 510(k) clearances under its listings, the newest dated June 9, 2026. 6 recall events name it as the recalling firm. 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.
- FDA registration number
- 3005718816
- Address
- 44650 Helm Court, Plymouth, MI, United States, 48170
- Owner or operator
- MATERIALISE N.V. (9029485)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 11, 2003
- Registered through
- 2026
- Brand names listed
- Acetabular Guide, AnatomyPrint, AtlasPlan Shoulder System, BKS Total PSI, Bespoke PSI, Bespoke Patient Specific Instruments, CMF Plastic Models, CMF Titanium Guides 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| March 21, 2018 | K173619 | Mimics inPrint | LLZ | 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 |
| July 20, 2012 | K112389 | SURGICASE CONNECT, SURGICASE GUIDE | PBF | Substantially Equivalent | Materialise NV | accessdata.fda.gov |
| June 15, 2012 | K111863 | SIGNATURE PLANNER,SIGNATURE GUIDES | JDI | 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 |
| March 27, 2012 | K111558 | SURGICASE GUIDE | HAW | 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 |
| March 18, 2011 | K103136 | SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE | JEY | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 13, 2022 | 90704 | Class II | Completed | ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208 | MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK | accessdata.fda.gov |
| May 3, 2016 | 74213 | Class II | Terminated | Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set. | A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used. | accessdata.fda.gov |
| October 16, 2014 | 69632 | Class II | Terminated | Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding | The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification. | accessdata.fda.gov |
| November 26, 2013 | 67039 | Class II | Terminated | REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized | Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert. | accessdata.fda.gov |
| November 8, 2013 | 66935 | Class II | Terminated | ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. | Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information. | accessdata.fda.gov |
| March 23, 2012 | 61699 | Not yet classified | Terminated | PATIENT SPECIFIC INSTRUMENTS LPS-FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID--0242-LF Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient spec | March 23, 2012 a field representative reported patient specific -0242-L tibia guide case packaging contained a different patient specific -0864-R tibia guide. The two patient specific products had been switched in packaging. Neither products had been delivered to the end user. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Knee Arthroplasty Implantation System
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- All makers of System, Image Processing, Radiological
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.