5. SPECIALTY: HIP CATEGORY: TRAUMA SOLUTIONS FOCUS: PLATES & SCREWS (1) 6.5/8.

0 mm Large Cannulated Screws

The 6.5/8.0 mm Large Cannulated Screw System is part of a series of modular systems developed by DePuy Orthopaedics, Inc., for cannulated screws ranging from 3.5 to 8.0 mm. The 6.5/8.0 mm screws feature four cutting flutes for excellent self-drilling and selftapping capabilities while the unique reverse radial tapping facilitates easy removal. A large 3.2 mm guide wire assists the surgeon with added stability and ease of insertion during the procedure. The 6.5/8.0 mm screws also offer the benefits of TiMAX titanium alloy, including increased strength, biocompatibility and enhanced imaging capabilities over standard titanium alloy and stainless steel. The system features numerous screw options in one convenient case two different 6.5 mm thread lengths and an 8.0 mm screw for maximum purchase in osteoporotic bone. The 6.5/8.0 mm modular screw case is formatted for quick surgical procedures with removable screw blocks allowing for rapid and easy interoperative use. This enhanced system is truly designed with the surgeon in mind. Screws, Plates, Intramedullary Nails, Compression Hip Screws, Pins and Wires Essential Product Information Important: This Essential Product Information does not include all of the information necessary for selection and use of a device. Indications: The use of metallic surgical appliances provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. These implants are intended as a guide to normal healing, and are NOT intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or nonunions in the presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue. All metal surgical implants are subjected to repeated stress in use, which can result in metal fatigue.

Contraindications: Screws, plates, intramedullary nails, compression hip screws, pins and wires are contraindicated in: active infection, conditions which tend to retard healing such as blood supply limitations, previous infections, insufficient quantity or quality of bone to permit stabilization of the fracture complex, conditions that restrict the patients ability or willingness to follow postoperative instructions during the healing process, foreign body sensitivity, and cases where the implant(s) would cross open epiphyseal plates in skeletally immature patients. Additional Contraindication for Orthopaedic Screws and Plates only: Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized. Additional Contraindication for Retrograde Femoral Nailing: A history of septic arthritis of the knee and knee extension contracture with inability to attain at least 45 of flexion. Additional Contraindications for Compression Hip Screws only: Inadequate implant support due to the lack of medial buttress. Warnings and Precautions: Bone screws and pins are intended for partial weight bearing and non-weight bearing applications. These components cannot be expected to withstand the unsupported stresses of full weight bearing. Adverse Events: The following are the most frequent adverse events after fixation with orthopaedic screws, plates, intramedullary nails, compression hip screws, pins and wires: loosening, bending, cracking or fracture of the components or loss of fixation in bone attributable to nonunion, osteoporosis, markedly unstable comminuted fractures; loss of anatomic position with nonunion or malunion with rotation or angulation; infection and allergies and adverse reactions to the device material. Surgeons should take care when targeting and drilling for the proximal screws in any tibial nail with oblique proximal screws. Care should be taken as the drill bit is advanced to penetrate the far cortex. Advancing the drill bit too far in this area may cause injury to the deep peroneal nerve. Fluoroscopy should be used to verify correct positioning of the drill bit. Additional Adverse Events for Compression Hip Screw only: Screw cutout of the femoral head (usually associated with osteoporotic bone). CATEGORY: Trauma Solutions FOCUS: Intramedullary Nail (2) AFFIXUS Hip Fracture Nail

The AFFIXUS Hip Fracture Nail System treats a wide range of proximal femoral fracture indications using a single set of user-friendly instruments, and combines the principles of a compression hip screw with the biomechanical advantages of an intramedullary nail.

Listed below are just a few of the main features that make this system unique:

The anatomic bends of the nail are important features. This hip fracture nail includes a 3 distal bend, paired with a chamfer on the front of the distal tip of the nail. Combined, these features facilitate ease of insertion through the proximal intertrochanteric/subtrochanteric region, and decrease the risk of anterior cortex penetration. Also, the 1.8m radius of curvature accommodates the anterior bow of the femur.

GOAL POST Technology is designed to facilitate visualization of the femoral neck on the lateral view in order to more accurately place the guide pin for the lag screw placement. The anterior and posterior metal posts on the proximal aspect on the insertion jig allow for an unobstructed fluoroscopic view down to the base of the femoral neck, and assist with fine tuning of the guide pin before it is fully seated in the femoral head.

The AFFIXUS Hip Fracture Nail comes with a pre-assembled set screw to eliminate fiddle factor and save time in the OR. This pre-assembled set screw engages with the lag screw to create a nonrotational or non-compression device. This set screw can engage the lag screw before or after inserting an optional anti-rotational screw. If compression is needed, one quarter back will allow for dynamic compression.

Screws, Plates, Intramedullary Nails, Compression Hip Screws, Pins and Wires Important: This Essential Product Information does not include all of the information necessary for selection and use of a device.

Indications: The use of metallic surgical appliances (screws, plates, intramedullary nails, compression hip screws, pins and wires) provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. These implants are intended as a guide to normal healing, and are NOT intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or nonunions in the presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue. All metal surgical implants are subjected to repeated stress in use, which can result in metal fatigue. Contraindications: Screws, plates, intramedullary nails, compression hip screws, pins and wires are contraindicated in: active infection, conditions which tend to retard healing such as blood supply limitations, previous infections, insufficient quantity or quality of bone to permit stabilization of the fracture complex, conditions that restrict the patients ability or willingness to follow postoperative instructions during the healing process, foreign body sensitivity, and cases where the implant(s) would cross open epiphyseal plates in skeletally immature patients. Additional Contraindication for Orthopaedic Screws and Plates only: Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized. Additional Contraindication for Retrograde Femoral Nailing: A history of septic arthritis of the knee and knee extension contracture with inability to attain at least 45 of flexion. Additional Contraindications for Compression Hip Screws only: Inadequate implant support due to the lack of medial buttress. Warnings and Precautions: Bone screws and pins are intended for partial weight bearing and non-weight bearing applications. These components cannot be expected to withstand the unsupported stresses of full weight bearing. Adverse Events: The following are the most frequent adverse events after fixation with orthopaedic screws, plates, intramedullary nails, compression hip screws, pins and wires: loosening, bending, cracking or fracture of the components or loss of fixation in bone attributable to nonunion, osteoporosis, markedly unstable comminuted fractures; loss of anatomic position with nonunion or malunion with rotation or angulation; infection and allergies and adverse reactions to the device material. Surgeons should take care when targeting and drilling for the proximal screws in any tibial nail with oblique proximal screws. Care should be taken as the drill bit is advanced to penetrate the far cortex. Advancing the drill bit too far in this area may cause injury to the deep peroneal nerve. Fluoroscopy should be used to verify correct positioning of the drill bit. Additional Adverse Events for Compression Hip Screw only: Screw cutout of the femoral head (usually associated with osteoporotic bone).

CATEGORY: AltrX Altralinked Polyethylene FOCUS: Acetabular Cups/Femoral Heads (3) AltrX Altralinked Polyethylene

AltrX is an ultra-low-wear polyethylene that offers a viable alternative-to-alternative bearings. The AltrX polyethylene uses a unique Altralink material enhancement process to optimize the balance between wear resistance and mechanical integrity. After moderate cross-linking, a remelting process eliminates all free radicals and oxidative potential and provides excellent mechanical integrity. Total Hip Prostheses, Self-Centering Hip Prostheses and Hemi-Hip Prostheses Essential Product Information Important: This Essential Product Information sheet does not include all of the information necessary for selection and use of a medical device. Intended Use Total Hip Prosthesis: Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Indications Total Hip Prosthesis: Total hip replacement is indicated in the following conditions: A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, certain cases of ankylosis. Intended Use-Self-Centering Hip Prosthesis and Hemi-Hip Prosthesis Self-Centering Hip Prostheses and Hemi-Hip Prostheses are intended to be used for hemi-hip arthroplasty where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.

Indications-Self-Centering Hip Prosthesis and Hemi-Hip Prosthesis Hemi-hip arthroplasty is indicated in the following conditions: Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation, fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation, avascular necrosis of the femoral head, nonunion of femoral neck fractures, certain high subcapital and femoral neck fractures in the elderly, degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement, pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. Contraindications: The following conditions are contraindications for total or hemi-hip replacement: Active local or systemic infection; Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified; Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s); Charcot's or Paget's disease; For hemi-hip arthroplasty, any pathological condition of the acetabulum, such as distorted acetabuli with irregularities, protrusio acetabuli (arthrokatadysis), or migrating acetabuli, that would preclude the use of the natural acetabulum as an appropriate articular surface for the hemi-hip prosthesis; Ceramic heads are contraindicated in revision surgery when the femoral stem is well fixed and is not being replaced; In the USA and Canada, ceramic heads are not approved for use with metal inserts. CAUTION: The following conditions, singularly or concurrently, tend to impose severe loading on the affected extremity, thereby placing the patient at higher risk for failure of the hip replacement: obesity or excessive patient weight, manual labor, active sports participation, high levels of patient activity, likelihood of falls, alcohol or drug addiction, other disabilities, as applicable. CAUTION: The following conditions singularly or concurrently, tend to adversely affect the fixation of hip replacement implants: marked osteoporosis or poor bone stock, metabolic disorders or systemic pharmacological treatments leading to progressive deterioration of solid bone support for the implant (e.g., diabetes mellitus, steroid therapies, immunosuppressive therapies, etc.), history of general or local infections, severe deformities leading to impaired fixation or improper positioning of the implant, tumors of the supporting bone structures, allergic reactions to implant materials (e.g., bone cement, metal, polyethylene), congenital dysplasia of the hip which may reduce the bone stock available to support the acetabular cup prosthesis in total hip replacement, tissue reactions to implant corrosion or implant wear debris, disabilities of other joints (i.e., knees and ankles). Emc Emcee Cmeo me Cme-cme C je9cnediqncie

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