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CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include: - Intrabony periodontal osseous defects - Furcation defects - Bony defects or bony deficiencies of the alveolar ridge - Intraoral, maxillofacial, and mandibular augmentation - Bony defects of the upper or lower jaw - Filling of tooth extraction sites - Sinus elevation grafting

CMFlex™ is a synthetic bone grafting material provided in block form of varying sizes (See Table 1.1) that can be easily trimmed or cut by the surgeon to fit the patient's bone defect(s). CMFlex™ is composed of majority synthetic hydroxyapatite powder bound by minority biodegradable polylactide-co-glycolide. CMFlex™ is fabricated via extrusion-based 3D-printing of liquid inks into regular porous structures. The combined macroscopic 3D-printed porosity, microporosity within the printed struts, and micron-sized hydroxyapatite particles gives CMFlex unique microstructural and physical properties. CMFlex™ is an osteoconductive, highly absorbent, and flexible bone graft that can be used in defects where new bone is needed. Although it is not intended for immediate load bearing applications, the implant remodels over time and is replaced by new bone tissue, functioning in the same manner as the predicate device. The blocks are provided sterile and are intended for single use. There are no accessories associated with CMFlex™.