MimetikOss. Instructions for use PRODUCT DESCRIPTION MimetikOss is a synthetic, porous, biocompatible graft used to fill multiple osseous defects. It is an osteoconductive macroporous implant made of synthetic β -tricalcium phosphate (20%) and biomimetic hydroxyapatite (80%). It has a multidirectional interconnected porous structure, similar to that of the human cancellous bone. MimetikOss is a granular graft with sizes ranging from 0.2 and 1 mm for the S version, and 1 to 2 mm for the M version. MimetikOss is a bone grafting material. Interaction of MimetikOss with drugs or other medicinal products is not known so far. INDICATIONS - Cranio-maxillofacial / Dental : Sinus lift, alveolar filling, peri-implantation filling, affixed graft, inlay/ onlay graft, maxillary distraction. Craniofacial plastic surgery. - Spine : Spine fusion, spinal cage filling. - Iliac crest harvesting - Upper limb: Humeral head fracture, glenoid prosthesis, humeral fracture, distal radius fracture. - Lower limb: Femoral head fracture, femoral nail revision, screws ablation, hip prosthesis, Knee prosthesis, tumoral filling, tibial fracture. - Foot: Calcaneus fracture, phalanx fusion, talus fusion. PRECAUTIONS The application of MimetikOss should be limited when the following disorders are known: - Acute and chronic infections in the surgery area (e.ge. soft tissue infections, inflammatory and bacterial osteopathy, osteomyelitis) - Severe metabolic disorders - Steroid treatments - Immunosuppressive therapy - Infectious and degenerative bone diseases - Immunodeficiency (congenital or acquired) - Oslerian risk - Unbalanced diabetes - Treatments acting on the calcium-phosphorus metabolism - Transient hypercalcemia As with any surgical procedure, care should be exercised in treating individuals with preexisting conditions that may affect the success of the surgical procedure. This includes (but is not limited to) individuals with long-term steroid therapy or treatment acting on the calcium or phosphorus metabolism. This product is contraindicated where the device is intended as structural support in the skeletal system. Conditions representing contraindications include also: - Implantation in necrotic surgical sites - Degenerative bone disease - Intra-articular implantations This product is to be handled or implanted by trained qualified personnel having read this instruction for use. Do not use if the patient is allergic/with known sensitivity to any of its components. Keep out of the reach of children. Do not use and inform if tube or blister are damaged, or if the expiration date has been exceeded. METHOD OF USE The vial which contains MimetikOss is packed into a blister and its content is sterile. For this reason the content of the blister should be handled in sterile conditions avoiding its contamination. The blister should be carefully opened in order to let the vial gently fall onto the sterile area. MimetikOss should be hydrated prior to implantation. MimetikOss is intended to be placed in bony voids or gaps that do not alter the stability of the bony structure. Do not overfill defects. Do not leave defect open (e.g. mucous well sutured and/or use of appropriate membrane). Do not compromise blood supply to the defect area. MimetikOss does not harden after implantation. Mechanical stability is reached once bone is formed around MimetikOss. It is recommended to avoid any possibility of leakage out of the cavity of implantation. Adequate postoperative immobilization is to be used with MimetikOss to prevent movement that may lead to soft tissue ingrowth. Until healing is complete, MimetikOss may not withstand weight. Post-surgery discharge is necessary. Implantation is not recommended in revision surgery site containing non resorbable biomaterials residues. STORAGE The product should be stored at room temperature. Use prior to expiry date printed on carton and blister. MimetikOss is supplied sterile in a vial. MimetikOss is sterilized by radiation. This device is for single patient use only and should not be resterilized. PRESENTATION - PACKAGING MimetikOss is available in a volume of 1 cm 3 (i.e. cc, mL) in a vial. S: 0.2 mm – 1 mm; M: 1 mm – 2 mm CONTACT Mimetis Biomaterials SL Av. Universitat Autònoma 23 Cerdanyola del Vallès, Spain +34 644324607 info@mimetis.com www.mimetikOss.com Rev. May 2017