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These devices are indicated for the following: Femur: - fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures; - proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures; - use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures in the femur; - mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal); - comminuted shaft fractures; - fixation of short distal or proximal fragments Tibia: - diaphyseal shaft fractures in the tibia; - comminuted shaft fractures; - fixation of short distal or proximal fragments Humerus: - diaphyseal shaft fractures in the humerus; - comminuted shaft fractures: - fixation of short distal or proximal fragments

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The Fixion Dynamic Hip Screw System (Fixion DHS) is intended for use in fixation of fractures in the proximal femur. The Fixion DHS is indicated for use in pertrochanteric, intertrochanteric, and base of femur neck fractures. The Fixion DHS can be implanted in an open or in a minimally invasive approach.

The Fixion DHS System consists of the following components: - Plate a solid, titanium-made, component, incorporating holes for the insertion of the Hip Peg, Locking Pin and Screws. The Plate Body is shaped to comply with the hone curvature and the Barrel is located at 135° - 145° relative to the Plate Body. - Hip Peg a titanium-made tube with a distal expandable section, to enhance the abutment of the Hip Peg inside the femoral head. The expandable body ends with a conical shaped distal end. - Locking Pin a titanium-made pin. It is used to provide additional fixation of the fragment, if needed, and for stabilizing bone fragments in case of torsional instability - Screws titanium screws. Maximum of 3 7 Screws (Plate length dependant) can be used to attach the plate to the bone (the femur shaft) at its distal section. - Instrumentation Set ~ a set of accessories to be used with the Fixion DHS implants. Accessories for both open and minimally invasive surgical approaches are available. - Inflation Device (Pump) - a manual pump used to expand the Hip Peg.

These devices are indicated for the following: Hip: - femoral head/neck fractures or non-unions; - aseptic necrosis of the femoral head/neck; and - osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement Femur: - fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures; proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures; - use in osteotomy, nonunions, bone reconstruction following turnor resection, grafting and pathological fractures, and revision procedures in the femur; - mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal); - comminuted shaft fractures: - fixation of short distal or proximal fragments Tibia: - diaphyseal shaft fractures in the tibia: - comminuted shaft fractures; - fixation of short distal or proximal fragments Humerus: - diaphyseal shaft fractures in the humerus; - comminuted shaft fractures; - fixation of short distal or proximal fragments

The Inflation Device (Nail Pump/Hip Peg Pump), which incorporates new materials and a slightly revised design, is still intended to operate in a manner similar to the Purnp currently used with the aforementioned Fixion Systems and all materials incorporated into it are already used in instrumentation supplied with those systems. The Fixion Interlocking Proximal Femoral Intramedullary Nailing System is substantially equivalent to the following cleared Fixion Systems: Fixion IM Nailing System - K990717. K003212, K003215, K010901, K021324; Fixion IL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fixion PF Nailing System (modified Pump) has the following similarities to that which previously received 510(k) clearance; - Have the same intended use - Have the same operating principles - The Implants and the Instrumentation Set incorporate the same design - The Implants and the Instrumentation Set incorporate the same materials - The Implants and the Instrumentation Set have the same basic packaging and sterilization, using the same materials and processes.

The Fixion Intramedullary Nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, tibia and femur. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal.

The Fixion Intramedullary Nailing System consist of the following main components: 1. The Nail Implant is an expandable, sealed, stainless steel, cylindrical, ribbed rod without interlocking holes. The proximal end has a one-way valve for expansion. The nail is cap protected. 2. The Insertion Handle is a device designed to be connected to the nail proximal end, and used for nail insertion. Its distal end has locking "teeth" to prevent relative rotation between the nail and the handle. 3. The Inflation Device is a pump, which rotation of its handle delivers saline into the nail. The pump pressure gauge indicates the expansion pressure. This action causes the nail expansion and abutment to the bone medullary cavity. In addition the system consists of additional accessories including a removal adapter, a slide hammer and a slide hammer adapter and a screwdriver.

The Fixion Interlocking Proximal Femoral Nailing System ("Fixion PF") is intended for use in fixation of fractures in the femur. The Fixion PF is indicated for use in fractures in the femur shaft, proximal fractures, and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric, intertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures. The long Fixion PF may also be used in mid shaft fractures, 5cm below the surgical neck to 5cm proximal to the distal end of the medullar canal. The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, revision procedures.

The Fixion Intramedullary Proximal Femoral Nailing System consist of the following main components: 1. The Nail Implant is an expandable non-slotted stainless steel cylindrical tube, with a cap protected, female threaded proximal end with holes for Femoral Neck Peg (Hip Peg) and Hip Pin. Other implantable components provided are the Femoral Neck Peg (Hip Peg) and the Hip Pin. 2. The Instrument Set consists of a few accessories used during insertion and removal (if required) of the implant. 3. The Inflation Device (Pump) is a single-use manual plastic pump that is filled with sterile inflation liquid and used to expand the Nail implant and Femoral Neck (Hip) Peg Once the Nail and the Femoral Neck Peg are positioned within the medullary canal and femur neck respectively, rotation of the pump handle allows for peg and nail diameter increase to their intended diameter under x-ray and controlled pressure. The Hip Pin may be inserted as well.

The Fixion™ Intramedullary Nailing System ("Fixion" Nail") is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, femur and the tibia. It is indicated for use in shaft fractures 5cm below the surgical neck to 5cm proximal to the distal end of the medullary canal.

The Fixion™ Intramedullary Nailing System is a single use system that features 3 main components: Nail implant, Driver, and Inflation device. - The Nail implant is an expandable non-slotted stainless steel cylindrical tube, with a conical shaped distal end and a cap protected, female threaded proximal end. - The Driver is a stainless steel cylinder with plastic handle. used for the nail insertion, location and adjustment at the intramedullary canal. In addition, it serves as a delivery system for the inflation liquid. The Driver has a male threaded end to be connected to the Nail implant proximal end. A quick connector is located on the Driver to be connected to the Inflation device. - The Inflation device is a single use manual plastic "pump", filled with sterile inflation liquid, similar to a PTCA inflation pump but with higher pressure. The inflation device outlet pipe end has a female quick connector to be connected to the Driver connector. Once the nail is positioned within the medullary canal, rotation of the "pump" handle allows for nail diameter increase to its intended diameter under X-ray and controlled pressure.