Company
Materialise N.V.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2023 | Materialise N.V. ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures.
Identificatio Completed |
JEY | K103136 |
| Jul 20, 2023 | Materialise N.V. MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-oper Completed |
JWH | K173445 K221337 |
| Jul 17, 2020 | Materialise N.V. Match Point System
The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthro Terminated |
KWS | K153602 K170893 |
| Feb 3, 2020 | Materialise N.V. TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013 Terminated |
JEY | K170272 |
| Feb 3, 2020 | Materialise N.V. TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 Terminated |
JEY | K170272 |
| Oct 23, 2015 | Materialise N.V. Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient C Terminated |
OSF | K102795 |
| Mar 17, 2015 | Materialise N.V. Signature TKA GDE/MDL Set 04-05 (Femur & Tibia)
The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be Terminated |
JWH | K102795 |