Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery combines 3D preoperative planning software with patient-matched titanium guides and plastic models to guide bone marking and surgical instrument placement during facial reconstruction and orthognathic surgery. The CMF Titanium Guides are used during bone repositioning/reconstruction for orthognathic and reconstruction indications in children, adolescents, and adults. The CMF Plastic Models are used for anatomical visualization and surgical planning in infants, children, adolescents, and adults.

The subject device uses additive manufacturing (Selective Laser Melting for titanium guides; Selective Laser Sintering or Stereolithography for plastic models) to produce patient-specific devices, whereas the predicate device includes both traditional subtractive and additive manufacturing methods. Both are non-sterile devices requiring hospital steam sterilization. The subject device is narrower in scope, limited to guides and models only, while the predicate collectively includes implants, plates, guides, models, and splints.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), ISO 10993-11 (pyrogenicity), ISO 10993-17 (leachable substances), ISO 10993-18 (chemical characterization), ISO 17665-1:2006 (steam sterilization validation). Compatibility testing with DePuy Synthes Matrix screw systems and Materialise Standard+ Solutions instrumentation was performed.

The subject device shares the same intended use and principles of operation as the predicate—converting patient medical images to virtual models for surgical planning and fabricating patient-specific surgical guides. Although the subject device expands the pediatric population (including children and infants for plastic models, compared to adolescents/adults in prior clearances), this expansion is supported by risk mitigation assessment based on FDA pediatric guidance and peer-reviewed clinical data. The mechanical, biocompatibility, and sterilization performance are equivalent, and the use of additive-only manufacturing does not raise new safety or effectiveness concerns because it employs identical methods cleared in prior submissions and produces functionally equivalent devices with validated properties.