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The SMV Scientific 2.4mm and 3.0mm Cannulated Screws are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The SMV Scientific 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation. The SMV Scientific 4.5mm Cannulated Screws is intended for fracture fixation of long bones and long bone fragments. The SMV Scientific 6.5mm and 7.3mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.

The SMV Scientific Cannulated Bone Screws consist of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided non-sterile. Screws are manufactured from Stainless Steel per ASTM F138 or Titanium per ASTM F136 or F1295.

The 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g .: - tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies - tarsometatarsal and metatarsophalangeal arthrodeses - ligament fixations - hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is intended for arthrodesis and osteotomies of small joints, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with large fragments, e.g.: - femoral neck fractures - intercondylar femoral fractures epiphyseolysis of the femoral head - ankle arthrodeses. Additionally, the 6.5 SMV Scientific Cancellous Screw and Washer is intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are manufactured from medical grade stainless steel. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are offered in various diameters and lengths. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are intended to provide fracture fixation. Implants are provided nonsterile with instructions for sterilization.

The SMV Scientific Schanz Screws are intended for use as external fixation for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

SMV Scientific Schanz Screws are manufactured from medical grade stainless steel. SMV Scientific Schanz Screws are offered in various diameters and lengths. SMV Scientific Schanz Screws are intended to provide fracture fixation.

The SMV Bone Plate and Screw System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, periarticular and intraarticular fractures.

The SMV Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates, bone screws for fixation, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths. Plates and screws are provided non-sterile. The implants in this submission can be used with the screws cleared in K150981 and K150188.

The SMV Scientific 2.0mm and 2.4mm Bone Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The SMV Scientific 2.7mm Bone Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The SMV Scientific 3.5mm and 4.0mm Bone Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle. scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The SMV Scientific 4.5mm Bone Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The SMV Scientific Bone Screws consist of cortical screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided both sterile and non-sterile. Screws are manufactured from stainless steel.