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FDA 510(k)

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models

K-Number: K253308 · 2026-01-07

ApplicantMaterialise NV
Decision Date2026-01-07
Product CodePPT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2026-01-07 under approval number K253308. The device is classified under product code PPT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models?

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models is a medical device that received FDA 510(k) clearance on 2026-01-07. It is manufactured by Materialise NV. The 510(k) number is K253308.

When was Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models approved by the FDA?

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models received FDA 510(k) clearance on 2026-01-07, under approval number K253308.

What company makes Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models?

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models is manufactured by Materialise NV.

What is the FDA product code for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models?

The FDA product code for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models is PPT.

Related Clinical Trials

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Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41966058 Artificial intelligence in personalized prescription: A narrative review of promise, peril, and practicality. Therapie (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40563006 Toward Transparent AI-Enabled Patient Selection in Cosmetic Surgery by Integrating Reasoning and Medical LLMs. Aesthetic plastic surgery (2025)

Other Devices by Materialise NV

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Related Devices (Code: PPT)

K151285VSP Cranial System3D Systems, Inc. K182889KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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