Cleared Special

K253308 - Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides (FDA 510(k) Clearance)

Also includes:
CMF Plastic Models

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253308 · Materialise NV · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
100d
Days
Class 2
Risk

K253308 is an FDA 510(k) clearance for the Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CM.... Classified as Cranial Surgical Planning And Instrument Guides (product code PPT), Class II - Special Controls.

Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on January 7, 2026 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K253308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 148d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PPT Cranial Surgical Planning And Instrument Guides
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.