Materialise NV: FDA clearances and approvals
Materialise NV has 61 FDA 510(k) clearances (first 1997, latest 2026), across 14 product codes in 4 review panels. Median 510(k) review time: 120 days. Since 2017 its median was 89 days, against 120 days for all cleared 510(k)s in the same product codes. It files with the SEC as MATERIALISE NV (MTLS).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 7 | 184 |
| 2013 | 1 | 120 |
| 2014 | 4 | 134 |
| 2015 | 2 | 171 |
| 2016 | 2 | 109 |
| 2017 | 6 | 86 |
| 2018 | 4 | 154 |
| 2019 | 3 | 139 |
| 2020 | 2 | 72 |
| 2021 | 0 | — |
| 2022 | 4 | 165 |
| 2023 | 3 | 34 |
| 2024 | 4 | 84 |
| 2025 | 2 | 71 |
| 2026 | 4 | 95 |
Review time against the same product codes
Since 2017, Materialise NV's cleared 510(k)s took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 16 | 16 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 13 | 13 |
| QHE | Shoulder Arthroplasty Implantation System | 9 | 9 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 5 | 5 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 4 | 4 |
| JEY | Plate, Bone | 3 | 3 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 3 | 3 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 | 2 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 1 | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
Plus 4 more product codes.
Review panels
- Orthopedic (39)
- Radiology (16)
- Dental (4)
- Neurology (2)
Most recent Materialise NV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260802 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | 2026-06-09 | 90 |
| K251964 | Mimics Thoracic Planner | LLZ | 2026-03-12 | 259 |
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models | PPT | 2026-01-07 | 100 |
| K253793 | Materialise TKA Guide System | JWH | 2026-01-06 | 39 |
| K251554 | Materialise TKA Guide System | JWH | 2025-07-14 | 54 |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | DZJ | 2025-02-21 | 88 |
| K242813 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | 2024-10-18 | 30 |
| K223427 | Mimics Enlight CMF | LLZ | 2024-05-31 | 564 |
| K241143 | Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | QHE | 2024-05-22 | 27 |
| K233217 | Mimics Cardiac Planner | LLZ | 2024-02-12 | 137 |
51 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Materialise NV.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
SEC filings
MATERIALISE NV (MTLS): EDGAR filings, CIK 1091223. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Materialise NV have?
Materialise NV has 61 FDA 510(k) clearances (first 1997, latest 2026), across 14 product codes in 4 review panels.
How long does FDA take to clear Materialise NV's 510(k)s?
The median time from FDA receipt to decision across Materialise NV's cleared 510(k)s is 120 days. Since 2017: 89 days, versus 120 days for all cleared 510(k)s in the same product codes.
What devices does Materialise NV make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 16); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 13); QHE (Shoulder Arthroplasty Implantation System, 9).
Has Materialise NV had device recalls?
openFDA lists no recalls under a recalling firm name matching Materialise NV. Related entities may recall under other names.
Next steps
- See all 61 Materialise NV clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Materialise NV's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.