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The ACE® Proximal Humeral Nail is a single use device intended for fixation of proximal humeral fractures. The ACE® Proximal Humeral Nail System is indicated for fixation of proximal humeral fractures. 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.

The ACE® Proximal Humeral Nail System consists of an intramedullary nail, a slecve, and an end cap and is intended for the fixation of proximal three part humeral fractures. The short, straight nail is available in diameters of 8 and 10 millimeters and length of 150mm. It is designed to be inserted antegrade, in line with the intramedullary canal. The sleeve has been designed to lock all proximal screws to prevent backing out.

Intended Use: The ACE® A/R Humeral Nail is a single use device intended for fixation of humeral fractures. Indications for Use: The ACE® Antegrade Retrograde Humeral Nail System is indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.

The ACE® Antegrade Retrograde (A/R) Humeral Nail System includes an intramedullary nail, cancellous and cortical screws, and end caps and is intended for the firsting of humeral fractures. The nail is available in diameters of 7, 8, and 9 millimaters and lengths of 200-300mm, in 20mm increments. The nail incorporates anterior/posterior and lateral/medial screw holes, distal and proximal bends, a distal locking screw postcho may be inserted antegrade as well as retrograde.

- · Fixation of Metaphyseal Fractures of the Distal Tibia - · Proximal Metaphyseal Tibial Fractures - · Calcaneus Body Fractures - · Proximal Humeral Head/Shaft Fractures - · Distal Femur Fracture Comminuted Shaft Fractures - · Fixation of soft tissue, such as tendon and ligaments, to bone

The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. The DePuy ACE Spider Plate is also indicated for the fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.

- Pilon fractures distal tibial intra-articular fractures - High medial malleolar fractures - Low boot top type rotational distal extra-articular shaft fractures

The DePuy ACE TiMAX™ Medial Pilon Plate is a fracture fixation plate intended for use in pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft tractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with three screw holes and a central cutout. There are also two k-wire guide holes for the distal metaphyseal region and a partial hole with countersink in the distal end of the cutout. The plate thickness is 1.6 mm in the shaft region and is decreased to 1 mm in the distal region to facilitate contouring and maintaining anatomic reduction of the fracture. The plate is supplied with a form along the long axis of the plate and the surgeon is expected to complete the contouring to match the individual patient anatomy. The open architecture of the distal region allows easy contouring by the surgeon to accommodate the anatomical topography of the distal tibia and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw and 4.0mm cancellous screw. The plate is a universal plate and can be used on the right or left tibia. The DePuy ACE TiMAX™ Medial Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).

- · Fixation of Metaphyseal Fractures of the Distal Tibia - · Proximal Metaphyseal Tibial Fractures - · Calcaneus Body Fractures - · Proximal Humeral Head/Shaft Fractures - · Distal Femur Fracture -- Comminuted Shaft Fractures

The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.

- Distal intra-articular tibia fractures - Proximal tibia fractures - Proximal and distal humerus fractures

The DePuy ACE TiMAX™ Meta Plate has a triangular shaped projection at the end of a shaft portion. The shaft portion has compression slots with a pitch of 13mm which matches the small fragment, active compression plate. The plate thickness is 1.6mm in the shaft region and transitions to a thickness of 1mm in the triangular shaped metaphyseal region. A cut-out in the middle of the metaphyseal region provides an open architecture to facilitate contouring by the surgeon, to accommodate the anatomical topography of the distal tibia as well as other indicated anatomical regions, and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the 3.5mm cortical screw and the 4.0mm cancellous screw. The plate will be offered in two sizes: small (width=30mm) and large (width=38mm) with various lengths.

Cortical bone screws (alone) Intramedullary nails as locking bolts Screws with plates Where extra purchase in far cortex is required

The device is a nut with a 10mm hex. This nut is made from a composite of a UHMW Polyethylene nut with a built-in Titanium washer. The washer will aid in fixation in osteoporotic bone by helping to distribute the load against the bone.

- Pilon fractures - distal tibial intra-articular fractures - High medial malleolar fractures - Low Boot top type rotational distal extra-articular shaft fractures

The DePuy ACE TiMAX™ Pilon Plate is a fracture fixation plate intended for use in pilon fractures (distal tibial intra-articular fractures), high medial malleolar fractures, and low boot type rotational distal extra-articular tibial shaft fractures. The plate profile consists of a shaft portion with compression slots, a diamond-shaped structure with four screw holes and two k-wire guide holes for the distal metaphyseal region, and finally, an arm which wraps anteriorly to address the anterior crush fracture and facilitate articular surface reconstruction. The plate thickness is 1.6 mm in the shaft region and is decreased to 1 mm in the distal region to facilitate contouring and maintaining anatomic reduction of the fracture. The shaft portion is thicker for strength. The plate is supplied pre-formed to a contour, which closely matches the distal tibia anatomy. The general contour includes a medial bend from the distal metaphyseal region combined with an internal rotation. The most distal profile includes the anterior arm with a large bend from the medial to the anterior surface with the bend apex located adjacent to the anterior strut. The open architecture of the distal region allows easy contouring by the surgeon to accommodate the anatomical topography of the distal tibia and also to promote fracture healing. The screw holes have been designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw, 4.0mm cancellous screw, and the periarticular screw. The plate will be offered in a right and left model with various lengths of the shaft region. The DePuy ACE TiMAX™ Pilon Plate is manufactured from Titanium 6A1-4V ELI (per ASTM standard F136).

The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plates are designed to assist the surgeon in the management of: - Intra-articular fractures of the calcaneus . - Extra-articular fractures of the calcaneus .

The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is a fracture fixation plate intended for both intraarticular and extra-articular fractures of the calcaneus. The plate profile is an enclosed box structure with a smaller anterior section, larger posterior section, a distal to posterior angled strut for additional strength and 12 anatomically relevant screw hole locations. The plate thickness is 1mm and provides a low profile fit to reduce peroneal tendon irritation. The open architecture of the plate allows easy contouring by the surgeon to accommodate the anatomical topography of the calcaneous and also to promote fracture healing. The enclosed box structure has been shown in biomechanical testing to be stronger in intra and extra articular fractures of the calcaneous as well as analysis of the tuberosity shifting laterally and distally due to loading from the talus. The screw holes are also contourable, designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw, 4.0mm cancellous screw, and the periarticular screw. The plate has countersinks on both sides to allow universal application of the plate; the same plate may be used on either the right or left side. The plate will be offered in two sizes: small and large. The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is manufactured from Titanium 6Al-4V ELI (per ASTM standard F136).

Pins, when used in conjunction with the DePuy ACE Trippi-Wells Tong, DePuy ACE Standard Tong, DePuy ACE Universal Tong, or Open and Closed Back Halo Rings, may be used for stabilization of the cervical spine in stationary and mobile traction following: - Cervical fractures - Ligamentous injury of the cervical spine - Fusion or other surgery of the cervical spine

The skull pins, which pass through the halo ring or tong, are the only invasive component of the DePuy ACE cervical traction device. The new skull pins, ring and tong (fixed tip and spring loaded), now include a zirconia insert between the pin body and the pin tip. The zirconia insert eliminates the possibility of an electrical current passing to the patient which may cause a burning sensation at the pin insertion points.