Cleared Special

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

K253308 · Materialise NV · Neurology
Jan 2026
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K253308 is an FDA 510(k) clearance for the Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models, a Cranial Surgical Planning And Instrument Guides (Class II — Special Controls, product code PPT), submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on January 7, 2026, 100 days after receiving the submission on September 29, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K253308 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date January 07, 2026
Days to Decision 100 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code PPT — Cranial Surgical Planning And Instrument Guides
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310
Definition Software And Hardware For Surgical Planning To Create Patient-specific Anatomical Models, Surgical Templates, And Guides For Use In The Marking Or Cutting Of Cranial Bone For Neurosurgical Procedures.