K253308 is an FDA 510(k) clearance for the Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.4310. 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..
| 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 |
| 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. |