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METICULY Patient-specific titanium mesh implant is a device that is designed individually for each patient. This device is indicated for reconstruction of bony defects resulting from selective trauma of the cranial and craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer) during cranial and craniofacial surgery and reconstructive procedures.

METICULY Patient-specific titanium mesh implant is a device designed individually to replace each patient's bony defects (bony voids and/or bone deformities) in the cranial and/or craniofacial skeleton. The craniofacial skeleton comprises the frontal bone, temporal bone, sphenoid bone, parietal bone, occipital bone, supraorbital process and vomer bone. This patient-specific device is intended to be used with titanium screws. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The FDA-cleared commercially available titanium screws that can be used with the subject devices include the Jeil Medical's LeForte Neuro System screws (K141452), the Titanium miniplate system (K951690) and Micro titanium plate system (K951688). The surgeon approves the design of the mesh implant prior to fabrication of the implant device.

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