Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
FDA 510(k) K253308 · Materialise NV
510(k) numberK253308
Submission
- Device name
- Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
- Applicant
- Materialise NV
Leuven, BE - Received
- September 29, 2025
- Decision date
- January 7, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PPT – Cranial Surgical Planning And Instrument Guides
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4310
- Specialty
- Neurology
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.
Other 510(k)s with product code PPT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201052 | KLS Martin Individual Patient Solutions (IPS) Planning SystemPPT · Traditional | KLS-Martin L.P. | 08/31/2020SE |
| K182889 | KLS Martin Individual Patient Solutions (IPS) Planning SystemPPT · Traditional | KLS-Martin L.P. | 07/26/2019SE |
| K151285 | VSP Cranial SystemPPT · Traditional | 3D Systems, Inc. | 09/23/2016SE |
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| K251554 | Materialise TKA Guide SystemJWH · Traditional | 07/14/2025SE |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional | 02/21/2025SE |
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| K233217 | Mimics Cardiac PlannerLLZ · Traditional | 02/12/2024SE |
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Questions and answers
When was Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models cleared by the FDA?
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models (K253308) received a 510(k) decision of Substantially Equivalent on January 7, 2026, 100 days after the submission was received.
What is the product code of K253308?
The FDA product code is PPT – Cranial Surgical Planning And Instrument Guides, a Class II (moderate risk) device regulated under 21 CFR 882.4310.