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

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery consists of CMF Titanium Guides and CMF Plastic Models used in craniofacial surgery. The titanium guides direct bone marking and surgical instruments during bone repositioning and reconstruction procedures including orthognathic surgery and bone harvesting. The plastic models enable visualization of patient anatomy and preparation of surgical interventions for children through adults, and require physician training in craniomaxillofacial surgery.

The subject device has identical technological characteristics to the predicate device K243637. Both use additive manufacturing (Selective Laser Melting for titanium guides, Stereolithography/Selective Laser Sintering for plastic models) and are made from commercially pure titanium, acrylic resin, or polyamide. Both are provided non-sterile and require hospital steam sterilization before use. The subject device expands anatomical coverage from facial to craniofacial (adding cranial applications from reference devices K201052 and K111558).

ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), ISO 10993-11 (pyrogenicity), ISO 10993-17 (leachable substances), ISO 10993-18 (chemical characterization), and ISO 17665-1:2006 (steam sterilization validation). Biocompatibility testing demonstrated noncytotoxicity, nonsensitization, nonirritant response, and no pyrogenicity; sterilization validation showed both device types can achieve SAL of 10⁻⁶.

The subject device is substantially equivalent to predicate K243637 because it shares identical indications for use (except expanded to include cranial applications), identical technological characteristics, manufacturing methods, materials, and sterilization approach. Risk assessment does not raise new safety or effectiveness issues. For cranial use, the device contacts only the exterior skull bone rather than cerebrospinal fluid, and is not intended for implantation, further supporting equivalence to the non-implant predicate device.