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Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Fixation of proximal tibial metaphysis osteotomy. Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

The Elite™ Nitinol Fixation System, like primary predicate Speed Titan™ K133780, is a Nitinol implant for bone fixation and is designed to be delivered to the operating room in an "open" (legs parallel) and constrained state. The Elite™ Nitinol Fixation System was designed for surgeons who desire additional fixation points for increased rotational stability. The implant does not require any external heating. The implant is fully active at room and body temperature so that the legs compress after release from instrument (additional legs in Straight design compress in tandem). The primary differences between the Elite™ Nitinol Fixation System and the cleared Speed Titan™ K133780 are the configurations featured. The Speed Titan™ K133780 is a staple with two legs, while the Elite™ Nitinol Fixation System introduces three configurations: a Straight (with two and four legs), a Y-shape (three and four legs) and an H-shape (four legs).

The Nitinol Compression Plating System™ is indicated for: - Fractures of various bones, including the clavicle, pelvis, scapula, long bones (humerus, radius, ulha, femur, tibia and fibula), and small bones such as metacarpals, metatarsals and phalanges.

The BME Nitinol Compression Plating System™ (NCP) consists of a sterile bone plate offered in various configurations (outlined below) and sterile titanium screws. The Nitinol bone plate is situated on two bones, across the fracture site, with titanium locking screws extending through the plate and cortex. The Nitinol bone plate is activated at room temperature upon release from a constraining instrument. In its final configuration, the plate actively provides continuous compression across the fusion site. The NCP system contains plates and screws in the same shapes and sizes as those offered in the GPC system. The configurations of the BME system include Straight, T-shaped and X-shaped implants. The main difference between the BME Nitinol Compression Plating System™ and the primary predicate, GPC Medical Bone Fixation Plates and Screw System™ is that the NCP plate component is made of Nitinol and provides active compression while the GPC plate is made of titanium alloy (Ti-6Al-4V) and does not provide active compression. The second difference is that the BME implants are offered sterile and for single use, while GPC Medical offers their products as non-sterile. BME Nitinol Compression Plating System™ is a fully sterilized kit comprised of the bone plate, titanium screws, sizing templates and instruments. The GPC Bone Plates and Bone Screws are offered non-sterile in reusable trays.

The Speed™, Speed Shift™, Speed Titan™ and Speed ArcTM are indicated for: - Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. - Fixation of proximal tibial metaphysis osteotomy. ● - Hand and foot bone fragment and osteotomy fixation and joint arthrodesis. - Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

The Speed™ product family consists of nitinol staple implants offered in a range of sizes for bone fixation. The Speed™ product family consists of Speed™, Speed Shift™, Speed Arc™, and Speed Titan™ with the primary difference being the shape of the bridge. The bridges range from flat (Speed™ and Speed Titan™), arched (Speed Arc™), and stepped (Speed Shift™) to conform to patient and osteotomy anatomy. All of the Speed™ implants are delivered to the operating room with the legs parallel in a constraining plastic inserter. The implant is then released from the inserter and transformed by ambient and body heat after insertion so that the legs converge. The implants do not require any external heating; they are completely transformed at typical operating room temperatures or body heat. The difference between the Speed™ implant staples and the primary predicate implant staples are their heat activating temperature as well as bridge shape (stepped or curved). The predicate BME OSStaple™ requires an external heating unit to warm the staples and activate the compression function. The bundled implant staples are activated at typical operating room temperatures or body temperature, and provide active compression without an external heating requirement.