Chrysalis Intelligence · Sponsors · Materialise NV

Materialise NV

Leuven, BE · 19 510(k) clearances

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Total clearances
19
2020-03-20 → 2026-06-09
Last 12 months
4
Product codes
6
Most recent
2026-06-09
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QHE — — — 9 2026-06-09
LLZ System, Image Processing, Radiological Class II Radiology 4 2026-03-12
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class II Orthopedic 3 2026-01-06
PPT Cranial Surgical Planning And Instrument Guides Class II Neurology 1 2026-01-07
DZJ Driver, Wire, And Bone Drill, Manual Class II Dental 1 2025-02-21
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Class II Orthopedic 1 2020-10-02
Filings

All 510(k) clearances (19)

Date K-number Device Code Class Specialty
2026-06-09 K260802 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner QHE — —
2026-03-12 K251964 Mimics Thoracic Planner LLZ Class II Radiology
2026-01-07 K253308 Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models PPT Class II Neurology
2026-01-06 K253793 Materialise TKA Guide System JWH Class II Orthopedic
2025-07-14 K251554 Materialise TKA Guide System JWH Class II Orthopedic
2025-02-21 K243637 Materialise Personalized Guides and Models for Craniomaxillofacial Surgery DZJ Class II Dental
2024-10-18 K242813 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner QHE — —
2024-05-31 K223427 Mimics Enlight CMF LLZ Class II Radiology
2024-05-22 K241143 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner QHE — —
2024-02-12 K233217 Mimics Cardiac Planner LLZ Class II Radiology
2023-11-09 K233408 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner QHE — —
2023-09-12 K231112 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner QHE — —
2023-03-06 K230315 Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner QHE — —
2022-08-17 K220452 Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner QHE — —
2022-07-05 K221337 Materialise TKA Guide System JWH Class II Orthopedic
2022-06-15 K213684 SurgiCase Viewer LLZ Class II Radiology
2022-01-12 K212569 Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner QHE — —
2020-10-02 K202207 Materialise PKA Guide System HSX Class II Orthopedic
2020-03-20 K193560 Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner QHE — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence