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The Eleganz™ Fusion Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies. The screws are not intended for interference or soft tissue fixation.

The EleganzTM Fusion Screw System includes screws for bone fixation and a set of instruments used for screw site preparation and delivery. The device is offered in two non-sterile trays that contain the screw, Kirschner wire, bone preparation instrumentation and a driver. The screws and Kirschner wires are used to stabilize a fracture, osteotomy site, or joint so that healing and fusion may occur which achieves its intended function. The screws are available in solid and cannulated versions and are made from Ti6Al4V alloy. They range from 8-50 mm in length. The outer diameter is tapered, varying from 2.5 mm at the tail to 2.0 mm (solid) or 2.25 mm (cannulated) at the tip. The Kirschner wires are 316 stainless steel. The instrumentation includes a drill, driver handle, driver bit, depth gauge / countersink, Kirschner wire, and ball and socket reamers. The drills and driver components are cannulated. The drills are offered in two lengths. The driver handle is used with the driver bit to insert the screw as well as with the drill for hand drilling. The depth gauge measures the Kirschner wire to determine its depth in the bone. The countersink has cutting flutes for easier entry into the intramedullary canal. The ball and socket reamers create a spherical radius on joint surfaces for better bony fusion.

The TriMed® Small Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot. The TriMed® Large Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of large bones and large bone fragments in the hand, wrist, elbow, ankle, and foot.

TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium. The small screws are indicated to be used as an aid in fracture fixations, non-unions and osteotomies of small bones and small bone fragments; the large screws are indicated to be used in fracture fixations, non-unions and osteotomies of large bones and large bone fragments. The TriMed Compression Screws are designed to provide additional constraint of movement of a fractured/osteotomized bone and non-unions and are intended only as an aid to fix the fracture/osteotomy in place during the healing process.

The SnapHammer Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The SnapHammer Hammertoe Correction System is comprised of an additively manufactured titanium fixation device attached to a snap-off post. The snap-off post aids in a quick insertion and snaps off after implant has been threaded in. The implants are offered in Ø3.0mm and Ø3.50mm diameters and in lengths ranging from 12mm to 15mm. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.

The TITANEX® Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

The TITANEX® Screw Systems contain cannulated bone screws and general instrumentation as a reconstruction solution for foot and ankle applications. The screws are provided in various diameters and lengths with headed, headless, partially, and fully threaded configurations. The implants are composed of titanium alloy. The instrumentation are composed of stainless steels. The devices are provided non-sterile and are intended to be steam sterilized prior to use.

The Caliber Intramedullary Fixation System is indicated to repair an acute fracture, mal-union or non-union of the clavicle.

The Caliber Intramedullary Fixation System is an intramedullary bone fixation screw system used to repair an acute fracture, mal-union or non-union of the clavicle. The intramedullary implant consists of a cannulated screw with distal and proximal threads, a cross-screw receiving hole and a screw head. The diameter ranges from 4.5mm in lengths from 50mm to 120mm. Additionally, the subject device is self-tapping and self-tapping and is made from Titanium Alloy.

Quick-Start Screws are indicated for interference fixation of grafts for ligament reconstruction such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.

The Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw family of products are interference screws indicated for the fixation of grafts in ligament reconstruction procedures such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions. The screw is composed of medical grade titanium alloy and is supplied sterile for single use in both standard thread and reverse thread designs.

The Arthrex VAL KreuLock™ Compression Screws (2.7 mm solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, and clavicle. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7) and Distal Radius Plates. The Arthrex VAL KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, Osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates. The Arthrex VAL Screws (2.7 mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions, in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, and clavicle. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates. The Arthrex VAL Screws (3.5 mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex SS VAL KreuLock™ Compression Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 10 mm to 110 mm. The screws are sold single-use and non-sterile. The Arthrex SS VAL Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 8 mm to 110 mm. The screws are sold single-use and non-sterile.

Locking Screw,CoCrMo is indicated for the fixation of clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula, metacarpals, metatarsals and phalanges fractures.

Locking Screw, CoCrMo is used to fasten plates onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Locking Screw, CoCrMo consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, the bone screw shall be used in combination with the bone plate, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Locking Screw,CoCrMo is made of CoCrMo following ASTM F1537. Locking Screw,CoCrMo is provided as sterile and non-sterile. The implants are intended for single-use only.

The OsteoCoil™ Nitinol Compression System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of the small bones for wrist, hand, and foot.

This Traditional 510(k) is submitted to introduce the OsteoCoil™ Nitinol Compression System. The system consists of a 4.5mm, 6.5mm and 7.3mm screw available in 30mm in 5mm increment lengths and appropriate instrumentation to support implantation of the OsteoCol™ Nitinol Compression screws. The the OsteoCol™ Nitinol Compression System have the same technological characteristics as the predicate device, the Dynafuse Fixation System (K203595).

The Tigon Medical FIRE System is intended to provide the orthopedic surgeon with a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries. - Bone Loss Deficiencies/Deformities - · Latariet - Free bone block - Internal bone fixation for bone fractures, fusions, non-unions, and osteotomies in the foot, ankle, hand, and wrist.

The Tigon Medical Fractures, Instability, and Reconstruction (FIRE) System includes reconstruction devices that are designed to provide a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries. The system includes instruments that allow for the placement of the reconstruction device and screws. The reconstruction devices and screws are available in various sizes.