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

K253308 is the FDA 510(k) clearance record for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models, a class II device, cleared for Materialise NV on 2026-01-07 under FDA product code PPT (Cranial Surgical Planning And Instrument Guides). FDA's definition for product code PPT reads: "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". FDA records list 61 510(k) clearances for Materialise NV, from 1997-04-21 to 2026-06-09. As of 2026-09-10, FDA records show no recalls naming K253308.