METICULY Patient-specific titanium mesh implant

The METICULY Patient-specific titanium mesh implant is a custom-designed device made of titanium alloy (Ti-6Al-4V ELI) produced via laser powder bed fusion additive manufacturing. It is individually designed for each patient using CT data to reconstruct bony defects of the cranial and craniofacial skeleton (frontal, temporal, occipital, parietal, sphenoid bones, supraorbital process, vomer) resulting from traumatic injury during cranial and craniofacial surgery and reconstructive procedures.

The subject device is made of titanium Ti-6Al-4V ELI (Grade 23) fabricated via 3D laser powder bed fusion additive manufacturing, with dimensions ranging 20–200 mm length and 20–210 mm width. It differs from the predicate device in that it has larger maximum dimensions (predicate was 20–105 mm length/width) and expanded screw diameter capability (1.4–2.3 mm versus predicate's 1.4–1.8 mm), but shares the same material, manufacturing process, non-sterile state, and non-locking plate holes.

Testing complies with ASTM F3001-14 for additive manufacturing titanium specifications, ISO 10993 series (parts 1, 3–6, 10–11, 23) for biocompatibility, ISO 17665-1 and ISO 11737-1/2 for sterilization validation, ANSI AAMI ST72:2019 for bacterial endotoxins, USP standards for endotoxin and sterility testing, ASTM F88/F88M-23 and ASTM D7386-16 for packaging and transportation, and ISO 4288/ISO 25178 for surface roughness.

The subject device is substantially equivalent to the predicate METICULY Patient-specific titanium mesh implant (K210099) because both share identical intended use (reconstruction of cranial/craniofacial bone defects), the same material and manufacturing method (titanium via laser powder bed fusion), comparable design and performance characteristics, and similar sterilization and fixation approaches. Comparative mechanical testing (FEA, compression testing, and roughness evaluation) demonstrates equivalent performance, and the dimensional differences do not raise new safety or effectiveness concerns.