510(k) Report

FDA applicant

Materialise NV

Leuven, BE62 decisions1997–202613 recalls

FDA records 62 decisions for Materialise NV (Leuven, BE) from 1997 to 2026: 62 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and JWH (Prosthesis, Knee, Patellofemorotibial…). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 93 predicates, 74 of them its own earlier devices. 13 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Materialise NV’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2008: 22009: 12010: 12011: 52012: 72013: 12014: 42015: 22016: 22017: 62018: 42019: 32020: 22022: 42023: 32024: 42025: 22026 (partial year): 5
2007high 7 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2023

2011: 12012: 22013: 12014: 12015: 22016: 12020: 32023: 2
2007high 3 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Materialise NV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological16decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer13decisions
  • QHEShoulder Arthroplasty Implantation System9decisions
  • KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented5decisions
  • HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer4decisions
  • PBFOrthopaedic Surgical Planning And Instrument Guides3decisions

Also: JEY (3), MBH (2), DZJ (2), PLW (1), JDI (1), PPT (1).

How long do its 510(k) reviews take?

Since 2016, its 30 510(k)s took a median of 89 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 12 of its 30 were faster than that.

Whose devices does it build on?

Its devices cite 93 predicates; 74 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 159 times; 74 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K033849Simplant SystemMaterialise NV · 200420cite it
  • K183105Mimics MedicalMaterialise NV · 201917cite it
  • K073468MimicsMaterialise NV · 20089cite it
  • K053592Simplant DR. JamesMaterialise NV · 20067cite it
  • K102795Signature Planner; Signature GuidesMaterialise NV · 20117cite it
  • K111492Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific InstrumentsMaterialise NV · 20117cite it

What has FDA decided for it lately?

  • K260913CMF Titanium SplintsMaterialise NV · 2026
  • K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV · 2026
  • K251964Mimics Thoracic PlannerMaterialise NV · 2026
  • K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic…Materialise NV · 2026
  • K253793Materialise TKA Guide SystemMaterialise NV · 2026
  • K251554Materialise TKA Guide SystemMaterialise NV · 2025
  • K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV · 2025
  • K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV · 2024

All 62 as Materialise NV →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K103136ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the…Jun 19, 2023Class II
  • K221337MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific…Apr 26, 2023Class II
  • K153602Match Point System The Match Point System is intended to by uses as a surgical…Jul 17, 2020Class II
  • K170272TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013Feb 3, 2020Class II
  • K170272TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001Feb 3, 2020Class II
  • K102795Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.May 3, 2016Class II

Other applicant names beginning “Materialise”

FDA records each applicant name separately; these may or may not be the same firm.

Materialise Dental NV 5