Company · BE
Materialise NV
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2026. Name variants (Inc, Corp, punctuation) are merged.
62510(k) clearances (5 in 12 months)
8recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 17 |
| LLZ | System, Image Processing, Radiological | 16 |
| QHE | Shoulder Arthroplasty Implantation System | 9 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 5 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 4 |
| JEY | Plate, Bone | 3 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 3 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 2 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 |
| HWT | Template | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| PLW | Acetabular Cup Orientation System | 1 |
| PPT | Cranial Surgical Planning And Instrument Guides | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K260913 | CMF Titanium Splints Materialise NV, BE | DZJ |
| Jun 9, 2026 | K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Mar 12, 2026 | K251964 | Mimics Thoracic Planner Materialise NV, BE | LLZ |
| Jan 7, 2026 | K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models Materialise NV, BE | PPT |
| Jan 6, 2026 | K253793 | Materialise TKA Guide System Materialise NV, BE | JWH |
| Jul 14, 2025 | K251554 | Materialise TKA Guide System Materialise NV, BE | JWH |
| Feb 21, 2025 | K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery Materialise NV, BE | DZJ |
| Oct 18, 2024 | K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| May 31, 2024 | K223427 | Mimics Enlight CMF Materialise NV, BE | LLZ |
| May 22, 2024 | K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Feb 12, 2024 | K233217 | Mimics Cardiac Planner Materialise NV, BE | LLZ |
| Nov 9, 2023 | K233408 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Sep 12, 2023 | K231112 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Mar 6, 2023 | K230315 | Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Aug 17, 2022 | K220452 | Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Jul 5, 2022 | K221337 | Materialise TKA Guide System Materialise NV, BE | JWH |
| Jun 15, 2022 | K213684 | SurgiCase Viewer Materialise NV, BE | LLZ |
| Jan 12, 2022 | K212569 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner Materialise NV, BE | QHE |
| Oct 2, 2020 | K202207 | Materialise PKA Guide System Materialise NV, BE | HSX |
| Mar 20, 2020 | K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase S Materialise NV, BE | QHE |
| Jul 8, 2019 | K190286 | Materialise Glenoid Positioning System Materialise NV, BE | KWS |
| Jun 5, 2019 | K190874 | Materialise Mimics Enlight Materialise NV, BE | LLZ |
| Mar 27, 2019 | K183105 | Mimics Medical Materialise NV, BE | LLZ |
| Jul 10, 2018 | K173039 | TruMatch CMF Titanium 3D Printed Implant Materialise NV, BE | JEY |
| Jul 6, 2018 | K173970 | Materialise PKA Guide System Materialise NV, BE | HSX |
| Mar 21, 2018 | K173619 | Mimics inPrint Materialise NV, BE | LLZ |
| Feb 2, 2018 | K173445 | Materialise TKA Guide System Materialise NV, BE | JWH |
| Nov 20, 2017 | K172650 | Materialise PKA Guide System Materialise NV, BE | HSX |
| Nov 3, 2017 | K172054 | Materialise Glenoid Positioning System Materialise NV, BE | KWS |
| Aug 8, 2017 | K170272 | TruMatch CMF Titanium 3D Printed Implant System Materialise NV, BE | JEY |
| Jun 19, 2017 | K170893 | Materialise Glenoid Positioning System Materialise NV, BE | KWS |
| May 11, 2017 | K170419 | SurgiCase Viewer Materialise NV, BE | LLZ |
| Jan 18, 2017 | K163156 | SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides Materialise NV, BE | PBF |
| Nov 7, 2016 | K162273 | Materialise TKA Guide System Materialise NV, BE | JWH |
| Apr 26, 2016 | K153602 | Materialise Glenoid Positioning System Materialise NV, BE | KWS |
| Oct 27, 2015 | K150780 | Acetabular Cup Orientation System Materialise NV, BE | PLW |
| Aug 10, 2015 | K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides Materialise NV, BE | JWH |
| May 22, 2014 | K140027 | ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER Materialise NV, BE | JWH |
| Apr 10, 2014 | K132290 | SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDES Materialise NV, BE | PBF |
| Apr 2, 2014 | K140257 | SIGNATURE PLANNER, SIGNATURE GUIDES Materialise NV, BE | MBH |
| Feb 25, 2014 | K133162 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA Materialise NV, BE | JWH |
| Sep 27, 2013 | K131559 | MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES Materialise NV, BE | KWS |
| Dec 5, 2012 | K121640 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM Materialise NV, BE | JWH |
| Jul 20, 2012 | K112389 | SURGICASE CONNECT, SURGICASE GUIDE Materialise NV, BE | PBF |
| Jun 15, 2012 | K111863 | SIGNATURE PLANNER,SIGNATURE GUIDES Materialise NV, BE | JDI |
| Apr 27, 2012 | K113599 | SURGICASE CONNECT Materialise NV, BE | LLZ |
| Apr 2, 2012 | K113829 | ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE Materialise NV, BE | JWH |
| Mar 27, 2012 | K111558 | SURGICASE GUIDE Materialise NV, BE | HAW |
| Jan 6, 2012 | K112301 | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER Materialise NV, BE | HSX |
| Oct 13, 2011 | K111492 | ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS Materialise NV, BE | JWH |
Newest 50 of 62.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2022 | Materialise USA LLC ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear
Identification number SD900.208 Completed |
HWT | None listed |
| May 3, 2016 | Materialise USA LLC Signature TKA GDE/MDL Set 04-05
Patient-specific surgical guide and instrument set. Terminated |
JWH | K102795 |
| Nov 21, 2014 | Materialise USA LLC 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 intraoperat Terminated |
JWH | K121640 |
| Jan 3, 2014 | Materialise USA LLC 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 Terminated |
HRY | K110415 |
| Dec 26, 2013 | Materialise USA LLC ProPlan CMF Guide(s) Model(s)
REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only.
Used as surgical tools to transfer a pre-operative Terminated |
None listed | |
| Dec 26, 2013 | Materialise USA LLC 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-op Terminated |
None listed | |
| May 14, 2012 | Materialise USA LLC PATIENT SPECIFIC INSTRUMENTS
N-K FLEX PIN GUIDES (FEMUR AND TIBIA)
NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE
Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI
Distributed by Zimmer Terminated |
JWH | K111492 |
| May 14, 2012 | Materialise USA LLC 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, W Terminated |
JWH | K111492 |