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The Emerge Medical IM Nail System is intended to provide temporary stabilization in long bones including the femur, tibia and humerus of various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), correction osteotomy including malalignment, pathologic fractures, impending pathologic fractures, and tumor resections of specific bones. Specific Femoral indications may include supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures proximal to a total knee arthroplasty, and fractures distal to a hip joint. Specific Humeral indications according to AO classification may include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

The System consists of titanium alloy intramedullary (IM) nails locking screws and end caps. The rigid, cannulated IM nails are inserted into the medullary canal and available in a variety of styles and lengths with proximal and distal holes for locking screws.

The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. The system can be used for: Stabilization of soft tissues and fractures Polytrauma/multiple orthopedic trauma Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures Arthrodeses and osteotomies with soft tissue problems; failures of total joints Neutralization of fractures stabilized with limited internal fixation Non-unions/septic non-unions Intra-operative reductions/stabilization tool to assist with indirect reduction Unilateral rectilinear bone segment transport or leg lengthening

The Emerge External Fixation System consists of combination clamp, rod-to-rod clamp, rods, pins, Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (3) 6L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber. The Emerge External Fixation System is provided non-sterile.

The Emerge Medical Distal Radius Set is intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius and other small bones.

The Emerge Medical Distal Radius Set will include 6 and 9 locking hole head variations with pairs of locking and non-locking holes in the shafts to be used with a variety and screws to be FDA cleared and offered as a system of implants to be used for internal bone alignment and fixation of fractures of the radius. The system features plates with six and nine hole head variations with three and five hole shafts, 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 F139-12).

The indications for the Emerge Medical Small Fragment Locked Plating System are as follows for the two subsystems: The Emerge Medical Locking Medial Distal Tibia Plate Set is indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures. The Emerge Medical Locking Proximal Tibia Plate Set is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The Emerge Medical Small Fragment Locked Plating System Line Extension is not intended for use with active or latent infection, osteoporosis, insufficient quantity of bone/soft tissue, material sensitivity (if suspected tests should be performed prior to implantation), sepsis, and patients who are unwilling or incapable of following postoperative care instructions. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Emerge Medical Small Fragment Locked Plating System Line Extension consists of implants and instruments designed to be used for internal bone alignment and fixation of fractures of the tibia. The system features a single plate design, 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 F139-12), and offered in various widths, lengths, and thicknesses. Plates and screws are provided non-sterile.

The indications for the Emerge Medical Periarticular and Locking Large Fragment System are as follows for the two subsystems: The Emerge Medical Periarticular Locking Plate Set is intended for treatment of nonunions, mal unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, periprosthetic fractures, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The Periarticular Locking Plate Set is also intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular Condylar fractures in normal or osteopenic bone, periprosthetic fractures, and nonunions and malunions. The Emerge Medical Locking Large Fragment Set is intended for fixation of various long bones, such as the humerus, femur, and tibia. Emerge Medical Locking Large Fragment Set is also intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia. The set is also for use in fixation of periprosthetic fractures, osteopenic bone, and nonunions or malunions. The Emerge Medical Periarticular and Locking Large Fragment System is not intended for use with active or latent infection, osteoporosis, insufficient quantity or quality of bone/soft tissue, material sensitivity (if suspected tests should be performed prior to implantation), sepsis, patients who are unwilling or incapable of following postoperative care instructions. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Emerge Medical Periarticular and Locking Large Fragment System consists of implants and instruments designed to be used for internal bone alignment and fixation of fractures of the tibia and femur. The system features four (4) types of plates (4.5mm Locking Proximal Tibia Plate, 4.5 Locking Condylar Plate, Locking 4.5mm Narrow and Broad Plate, Locking T-Plate), 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 F139), and offered in various widths, lengths, and thicknesses. Plates and screws are provided non-sterile.

The indications for the Emerge Medical Bone Plate System are as follows for the four subsystems: The Emerge Medical Locking Mini Fragment System is intended for fixation of fractures, osteotomics, non-unions, deformations, revisions, replantations, of small bones and bone fragments including tarsals, metatarsals, carpals, metacarpals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone. The Emerge Medical Non-Locking Mini Fragment System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations of small bones and bone fragments including tarsals, metatarsals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone. The Emerge Medical Non-Locking Modular Hand System is intended for fixation of fractures, osteotomics, non-unions, deformations, replantations, of bones and bone fragments including phalanges, hand, and wrist, including in osteopenic bones. The Emerge Medical Modular Foot System is intended for fixation of fractures, ostcotomics, non-unions, deformations, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle, including in osteopenic bone.

The Emerge Medical Bone Plate System consists of stainless steel and titanium components including locking plates, cortex screws, cancellous screws, and washers. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The screws and plates are provided non-sterile.

The Emerge Medical Large Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, olecranon, ulna, humerus, femur, tibia, fibula, calcaneus, tarsals, and pelvis, including in osetopenic bone. The Emerge Medical Small Plate System is intended for fractures, osteotomies, nonunions, deformations, revisions, replantations, of bones and bone fragments including clavicle, scapula, olecranon, humerus, radius, ulna, tibia, fibula, tarsals, metatarsals, phalanges, and calcaneus, including in osetopenic bone.

The Emerge Medical Small and Large Non-Locking Fragment Plate System consists of stainless steel components. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The plates are provided non-sterile.

The Emerge Medical Small Fragment Locked Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

The System consists of stainless steel plates (including straight, reconstruction, periarticular t-plates, humerus, one-third tubular), standard cortex screws, locking cortex screws, standard cancellous screws, and washers. The plates are available in a variety of styles and lengths with the number of holes varying depending on plate length, and include threaded locking holes and non-threaded dynamic compression slots. The screws and plates are provided non-sterile. The Emerge Medical Small Fragment Locked Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

The Emerge Medical Locking One-third Tubular Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

The System consists of stainless steel components including locking plates and standard cortex screws, locking cortex screws and standard cancellous screws and washers. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The screws and plates are provided non-sterile.

The Emerge Medical Solid Bone Screws are intended to provide bone fixation in the management of osteotomies, fusions, and fractures of metaphysis and diaphysis of both small and large bones and the pelvis. The screws may be used alone or with washers.

The Emerge Medical Bone Fixation screws consist of cancellous, cortical and shaft screws with washers, as needed, in a variety of sizes to accommodate differing anatomic requirements. The screws are provided non-sterile.