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The ODi TALON™ Long Proximal Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures, and combinations of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

The ODi TALON™ Long Proximal Femoral Nail is used for fixation and stabilization of fractures of the proximal femur until bony union can occur. The system consists of the following parts: - A femoral nail with portals that allow passage of distal cortical screws and a proximal lag screw assembly. - The TALON™ Lag Screw used in the nail system is completely compatible with ODi's TALON™ Compression Hip Screw system and has been previously approved by the FDA in K984331. The TALON™ lag screw has deployable tangs to increase the purchase of the lag screw within the femoral neck/head. These tangs may also be retracted for removal of the lag screw if and when it is necessary. The distal end of the lag screw is keyed with a "double-d" shape, cannulated and internally threaded. This keyed shaft provides rotational stability for better lag screw purchase. The screw is internally threaded to allow the use of the compression screw to compress the fracture fragments. - A slotted sleeve which passes through the intramedullary nail. The sleeve is keyed to the lag screw assembly to prevent its rotation while allowing axial translation of the lag screw. - A sleeve lock which passes through the proximal end inner bore of the intramedullary nail. The sleeve lock has 2 positions within the intramedullary nail - "locked" and "unlocked". In the "locked" position, the legs on the sleeve lock mate with the slots in the sleeve thereby preventing rotation and axial translation of the sleeve, but allowing axial translation of the lag screw assembly. - A compression screw which shoulders against the slotted sleeve and engages the internal threads in the distal end of the lag screw assembly providing for axial compression of a proximal hip fracture. The compression screw is used to compress the fracture site by drawing the nail and lag screw portions together. The cortical screws have been previously approved by the FDA in K984331. - An end cap with both internal and external threads and a keying slot. The external threads engage the internal threads in the proximal end of the intramedullary nail and protect them from bony ingrowth for the possible future attachment of nail removal instrumentation for explantation. The internal threads in the end cap mate with the nail installation instrumentation. - Cortical screws are provided to cross-lock the distal end of the nail to the femoral shaft to help prevent axial translation or rotation of the nail. The cortical screws have been previously approved by the FDA in K984331. The nail will be provided in a pre-assembled condition with the sleeve lock and end cap already attached to save time in surgery. ODi will manufacture the implants from implant grade stainless steels.

The ODi 7.0mm Cannulated Screw System will be used on indications that are common with presently marketed cannulated screw systems. The primary indications are for fixation/stabilization of stable fractures of the proximal femur including pertrochanteric fractures, basilar femoral neck fractures, subcapital femoral fractures, and combinations of these fractures. Other indications include intercondylar femoral fractures and tibial plateau fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

The ODi 7.0mm Cannulated Screw System is used for fixation and stabilization of fractures of the proximal and distal femur until bony union can occur. The system consists of the following parts: - Cannulated screws of various lengths, which are positioned through bony fragments to provide stability to the fracture site during healing. - A washer which provides a bearing surface for the cannulated screw head against the bone. The washer also prohibits migration of the screw head into the cortex. ODi will manufacture the implants from implant grade titanium alloys.

The ODi Talon™ Intramedullary Hip Nail will be used on indications that are common with presently marketed intramedullary hip nail systems. The primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

The ODi Talon™ Intramedullary Hip Nail is used for fixation and stabilization of fractures of the proximal femur until bony union can occur. The system consists of the following parts: - An intramedullary nail with portals that allow passage of distal cortical screws . and a proximal lag screw assembly. The nail will be provided in a pre-assembled condition with the sleeve lock and end cap already attached to save time in surgery. - The Talon™ Lag Screw is completely compatible with ODi's Talon™ ● Compression Hip Screw system and has been previously approved by the FDA in K984331. The Talon™ lag screw has deployable tangs to increase the purchase of the lag screw within the femoral neck/head. These tangs may also be retracted for removal of the lag screw if and when it is necessary. The distal end of the lag screw is keyed with a "double-d" shape, cannulated and internally threaded. This keyed shaft provides rotational stability for better lag screw purchase. The screw is internally threaded to allow the use of the compression screw to compress the fracture fragments. - A slotted sleeve which passes through the intramedullary nail. The sleeve is . keyed to the lag screw assembly to prevent its rotation while allowing axial translation of the lag screw. - A sleeve lock which passes through the proximal end inner bore of the ● intramedullary nail. The sleeve lock has 2 positions within the intramedullary nail - "locked" and "unlocked". In the "locked" position, the legs on the sleeve lock mate with the slots in the sleeve thereby preventing rotation and axial translation of the sleeve, but allowing axial translation of the lag screw assembly. The sleeve lock is provided for surgery pre-assembled in the "unlocked" position within the intramedullary nail. - A compression screw which shoulders against the slotted sleeve and engages . the internal threads in the distal end of the lag screw assembly providing for axial compression of a proximal hip fracture. A polyethylene patch is embedded in the threaded portion of the compression screw to prevent rotation of the screw inside the lag screw after the desired amount of compression is reached.. The compression screw is used to compress the fracture site by drawing the nail and lag screw portions together. The compression screw has been previously approved by the FDA in K984331. - An end cap with both internal and external threads and a keying slot. The . external threads engage the internal threads in the proximal end of the intramedullary nail and protect them from bony ingrowth for the possible future attachment of nail removal instrumentation for explantation. The internal threads in the end cap mate with the nail installation instrumentation. The end cap is provided for surgery pre-assembled in the intramedullary nail. - Cortical screws are provided to cross-lock the distal end of the nail to the . femoral shaft to help prevent axial translation of the nail. The cortical screws have been previously approved by the FDA in K984331. The nail will be provided in a pre-assembled condition with the sleeve lock and end cap already attached to save time in surgery. ODi will manufacture the implants from implant grade stainless steels.

The ODi Ultimate Compression Hip Screw will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures, intracapsular fractures and some high subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. The installed device is not intended for weight bearing prior to the fracture showing evidence of union.

The Orthopedic Designs, Inc. Ultimate Compression Hip Screw is a cannulated lag screw to be used with a standard side plates for fracture fixation and stabilization of the proximal femur until bony union can occur. ODi will manufacture the hip screw system from 316L and 22-13-5 stainless steel, which meet ASTM F138-92 and ASTM F1314-95 respectively. The 22-13-5 is used on the side plate and the lag screw tang where greater strength is desired. These materials are compatible and similar to those used in other marketed devices of similar design, dimension and configuration. The distal end of the hip screw is keyed, but not threaded, thereby allowing the screw to slide within the barrel of the side plate while preventing rotation of the screw within the head of the femur. Several keyed sizes are available to be compatible with specific side plate systems of similar design. Immediate compression may be obtained with the use of a compression screw threaded into the inner canal of the screw. A locking element is provided on the compression screw to prevent a common natural migration of the compression screw from the lag attachment Additionally the hip screw has deployable tangs, comparable to several marketed anchor devices, that may be deployed if necessary to increase purchase of the lag screw. These anchors may also be retracted for removal of the lag screw if and when it is necessary. The hip screw and instruments are similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution. A range of screw component sizes and lengths sizes will be made available, offering a range of fracture compression. The components are designed to be manually or mechanically inserted using common (e.g. American Orthopedic) manual and power instrumentation.

The ODi Ultimate Compression Screw System™ was designed for use on indications comparable to those for approved and marketed devices. The primary indications are for the stabilization of osteotomies in small bones, and the fixation of unstable or interfragmentary fractures. This device is not intended for use in the spine. The ODi Ultimate Compression Screw™ is indicated for: 1. Small Hand Bone Fractures 2. Carpal and Metacarpal Fractures 3. Tarsal and Metatarsal Fractures 4. Distal Metatarsal Osteotomies (Austin Chevron, Scarf) 5. Interfragmentary Radius and Ulna Fractures 6. Osteochondral Fractures 7. Intra-articular fractures 8. Arthrodesis of small joints 9. Reconstructive osteotomies in small carpal or tarsal bones 10. Osteochondritis Dissecans 11. Oblique fractures of the fibula 12. Metatarsal osteotomies and other reconstructive surgeries in the foot

The ODi Ultimate Compression Screw™ will be offered in Ti-6Al-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. The Ultimate Compression Screw System™ consists of three screw components designed to be used as an assembly. The device has been designed to offer a wide range of compression, and screw sizes to address varving fracture and bone fragment geometries. The assembly consists of the following: - Proximal Screw Component . - Distal Screw Component . - Internal Compression Screw t The screw components are equivalent in design to currently marketed standard compression bone screws. The thread form and defining screw features conform to ISO 5835, Metal Bone Screws with Hexagonal Drive Connection, Spherical Under-Surface of Head, Asymmetrical Thread Dimensions. Initially, ten screw lengths will be available in 3.5 mm, 4.5 mm and 6.5 mm diameters, offering a range of fracture compression from 14.0 mm to 58.0 mm. The components are self-tapping and are designed to be manually inserted using commonly available (e.g. American Orthopedic) surgical instruments. All device components are manufactured from titanium alloy, Ti-6Al-4V, per ASTM F136 and provided in detail as follows: Proximal Screw Component The proximal screw component is provided in outer diameters of 3.5 mm, 4.5 mm and 6.5 mm. This allows for implantation into either cortical or cancellous bone. The surgeon selects the component diameter and length based upon the bone type and the size of the bone fragment requiring fixation. Distal Screw Component The distal screw component is provided in outer diameters of 3.5 mm, 4.5 mm, and 6.5 mm. This allows for implantation into either cortical or cancellous bone. The surgeon selects the component diameter and length based upon the bone type and the size of the bone fragment requiring fixation. Internal Compression Screw The 2.0 mm internal compression screw is designed to seat within the proximal component and thread into the distal component. As the internal compression screw is threaded into the distal screw component, it draws the proximal and distal screw components together, thereby achieving fracture fixation. Note that the internal compression screw is designed to universally fit all proximal and distal screw sizes. This gives the system a modularity that allows the surgeon to select the proximal and distal screw combination that best addresses the fracture geometry.