The METICULY Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).
A sterile implantable ocular device used to reconstruct the floor of the bony cavity that contains the eyeball and its associated muscles, vessels, and nerves, (i.e., the orbital floor and/or rim of the eye socket), and is intended to house an artificial eye. It may be constructed of one of a variety of materials, or a combination, including stainless steel, titanium (Ti), titanium alloy, or flexible mesh alloplastics. It is an aspherical orbital volume replacement prosthesis that will typically have a spongy outer surface (e.g., reinforced with surgical mesh) designed to encourage tissue attachment.