Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in BelgiumLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Materialise and its 2 subsidiaries with 67 510(k) clearances and 13 device recalls. The most recent is a 510(k) clearance dated Oct 9, 2026: CMF Titanium Splints.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Materialise and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 9, 2026 | CMF Titanium SplintsK260913 · DZJ | 510(k) clearances |
| Jun 9, 2026 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerK260802 · QHE | 510(k) clearances |
| Mar 12, 2026 | Mimics Thoracic PlannerK251964 · LLZ | 510(k) clearances |
| Jan 7, 2026 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsK253308 · PPT | 510(k) clearances |
| Jan 6, 2026 | Materialise TKA Guide SystemK253793 · JWH | 510(k) clearances |
| Jul 14, 2025 | Materialise TKA Guide SystemK251554 · JWH | 510(k) clearances |
| Feb 21, 2025 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryK243637 · DZJ | 510(k) clearances |
| Oct 18, 2024 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerK242813 · QHE | 510(k) clearances |
| Jul 13, 2022 | ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208Class II · MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK | Device recalls |
| May 3, 2016 | Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.Class II · A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not | Device recalls |
| Oct 16, 2014 | Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the Class II · The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral gui | Device recalls |
| Nov 26, 2013 | 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 Class II · Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert. | Device recalls |
| Nov 8, 2013 | ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Class II · Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan inf | Device recalls |
| Nov 8, 2013 | ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single UsClass II · Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan inf | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
