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The PK High Tibial Osteotomy Correction System is an external fixation device, which is intended for use in the treatment of the following indications in the tibia: - Temporary fracture fixation - Correction of deformity - Osteotomy - Bone union - Bone reconstruction - Fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality - Leg lengthening

The PK High Tibial Osteotomy Correction System is a single-use external fixator which consisting of the following components: fixation plate, cortex pin and cancellous pin. Pins are available in various lengths and diameters according to practical requirements. These pins and other components are manufactured from 316L stainless steel (ASTM F138/ ISO 5832-1) and aluminum alloy. These devices are intended to be used in the tibia. Adjustment of the fixator is possible during the course of treatment. All components are provided sterile.

The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non- unions of the proximal humerus

The AOS Anterolateral Proximal Humeral plates are open reduction internal fixation devices for the temporary fixation of various types of fractures of the humerus and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Anterolateral Proximal Humeral System consists of titanium plates, and proximal and distal locking and non-locking screws. 16 and 18 hole plates are being added to the system. The 16 hole plates are 9.4 inches long. The 18 hole plates are 10.4 inches long.

The Phantom™ Small Bone Intramedullary Nail System is indication and fixation of the small bones of the feet and ankle for the treatment of fractures, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures. The PhantomTM Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

The PhantomTM Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The PhantomTM nails are offered in a variety of lengths to accommodate variations in patient anatomy. The PhantomTM threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

The AOS Anterolateral Proximal Humeral Plate is indicated for fracture dislocations, osteotomies, and nonunions of the proximal humerus.

The AOS Anterolateral Proximal Humeral plates are open reduction internal fixation devices for the temporary fixation of various types of fractures of the humerus and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Anterolateral Proximal Humeral System consists of titanium plates, and proximal and distal locking and non-locking screws.

The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

The Orthofix Contours Proximal Humeral Plate (PHP) is a modified version of the Orthofix Titanium Humeral Plating System "LSP", cleared under 510(k) K062920. Like the predicate device, the Orthofix Contours Proximal Humeral Plate (PHP) is a locking titanium plate intended for the treatment of fractures. osteotomies and non-unions of the proximal humerus. The Orthofix Contours Proximal Humeral Plate (PHP) consists of a left and a right plate that has to be used in combination with at least two Diaphyseal Screws, a main locking screw and at least two titanium hexagonal Fine Threaded Screws. In addition titanium/polymeric cerclage wires can be used to achieve further stabilization of the bone fragments. Instrumentation is available for the insertion of the plates and screws. The modifications introduced with the Orthofix Contours Proximal Humeral Plate (PHP) are summarized below: - Dimensional changes, concerning width and central part height of the plate, diameter of some fixation points and lengths of the revision screws. - Sterilization configuration: Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration while the predicate device, Orthofix Titanium Humeral Plating System "LSP" is sold in a non-sterile configuration. - Packaging configuration: as the Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration, the packaging will be modified with respect to the predicate device.

The AOS Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The AOS Proximal Humeral Plate is an internal fixation device for the fixation of fractures of the humeral head and is intended as a load sharing device which may be removed once the fracture has healed. The plate is manufactured in multiple lengths with the overall length of the plate ranging from 97mm to 236mm. The proximal portion has eight 135° angled holes to accept 4.0mm locking screw. The distal portion has 3, 5, 8, 11 and 14 hole configurations which will accept a 4.0mm locking screw or a 3.5mm cortical screw. There are three associated screws for the AOS Proximal Humeral Plate; the 4.0mm fully threaded locking screws, the 4.0mm partially threaded locking screw and the 3.5mm cortical screw. The AOS Proximal Humeral Plates and screws are manufactured from titanium alloy. The overall length of the AOS Proximal Humeral Plate ranges from 97mm to 236mm while the proximal portion is consistent for all plates at 48mm. The proximal portion of the plate contains 8 threaded holes that accept the 4.0mm partially threaded cancellous locking screw. The proximal portion of the plate also contains six suture holes and a 2.0mm hole for positioning. The distal shaft of the plate is manufactured in 3, 5, 8, 11 and 14 hole configurations with the first hole being a slot. These threaded holes are staggered through the length of the plate and accept a 4.0mm fully threaded cancellous locking screw or the 3.5mm cortical screw.

The Synthes (USA) Modular Blade Plate System is indicated for fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.

The Synthes (USA) Modular Blade Plate System is comprised of a spiral blade that attaches to one end of a side plate, secured with a coupling screw to create a fixed angle construct. The Modular Plates are available in various configurations - 90°, 110°, 120° and 130° plates with off-sets, and 95° or 130° plates without off-sets. The Modular Plates have standard locking-compression holes (LCP) in the shaft and are available in a variety of lengths to accommodate varying injury, patient anatomy and size. The Modular Plates are available to be used with 4.5 mm Cortex screws or 5.0 mm Locking screws. The Spiral Blades rotate 90° clockwise or counterclockwise over the length of the blade. A variety of lengths are available to accommodate varying patient anatomy. The coupling screw is one size fits all plate and blade configurations.

The Orthofix Titanium Humeral Plating System is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

The Orthofix Titanium Humeral Plating System consists of bone plates and locking screws, made of a titanium alloy. The bone plate included in the system is designed to treat fractures of the proximal humerus and come in a right and left version. The plate has several locking options for the insertion of Fragment Fixations System implants (FFS), thus allowing a customized fragment adapted approach. Accessories include a cover to protect the ends of the FFS and a screw to lock this cover on the plate. Instrumentation is available for the insertion of the plates and screws.

The device is used for internal fracture fixation of small bone (toe, finger etc) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton).

Leforte system bone plate is made of unalloyed Titanium (ASTM F67-95 G1) and is manufactured and intended for internal fixation of small bones (toc, foot, finger, hand etc.) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton). Jeil Medical Co., Ltd. utilizes the state of the art technology and apply the essential requirement of MDD (93/42/EEC) and ISO 14630. 1997 from the device design to manufacturing and QC..

Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation aand treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.

External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.