Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
Materialise NVMaterialise Personalized Guides and Models for Craniomaxillofacial Surgery is a system that combines 3D surgical planning software with patient-specific physical guides and models to assist surgeons in facial bone surgeries. It helps surgeons visualize patient anatomy, plan interventions, and accurately carry out surgeries by guiding instruments and bone cutting based on a customized surgical plan created from medical images.
Intended Use
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery are intended to guide bone marking and surgical instruments in facial surgery, and for visualization, preparation, and fitting during mandibular and maxillofacial surgical procedures.
Technology
The system uses 3D pre-operative planning software to segment medical images and create 3D patient-specific virtual models. Using additive manufacturing technologies like Selective Laser Melting (for titanium guides) and Selective Laser Sintering or Stereolithography (for plastic models), it produces physical patient-matched devices constructed from commercially pure titanium or polyamide/acrylic materials.
Performance
The device underwent multiple non-clinical tests including compatibility with surgical screws and instruments, geometric accuracy and mechanical performance verified by surgeons, biocompatibility testing per ISO standards, and steam sterilization validation. Clinical safety and effectiveness in pediatric populations is supported by risk assessment and peer-reviewed clinical data.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/25/2024
2 months - 2
FDA Approval
2/21/2025
Other devices from Materialise NV
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