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Double Engine Intramedullary Nail System is intended to be implanted into the medullary canal of tibia for alignment, stabilization, fixation of fractures caused by trauma or disease.

Double Engine Intramedullary Nail System is composed of intramedullary nails, interlocking screws, and end caps. Intramedullary nails are provided in variety of lengths and anatomical deigns to accommodate the medullary canal of long bones (tibia). Interlocking screws are used for axial compression and preventing rotation. End caps on intramedullary nails are intended to facilitate removal and to allow length adjustment of the nail.

Double Engine Bone Plate and Screw Systems are provided non-sterile. Double Engine Bone Plate and Screw Systems are intended for fixation of various bone fracture, including large bone (clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).

Double Engine Bone Plate System consists of plates in various designs and size. Plates are provided in straight designs and various geometric configurations that are commonly used in traumatic and reconstructive surgery (Table 3.5.1). Plates are provided with screw holes to accommodate non-locking and locking screws. They are named according to both anatomical positions and biomechanical functions of the plates. The sets in size of Double Engine Bone Plate System are divided into four sets: large, small, mini, and reconstruction. The thickness of plates varies from 1.0 to 5.6mm, width from 3.8 to 43.6mm, length from 15.4 to 361mm, and hole number from 2 to 27 holes. Double Engine Bone Screw System is used either to fasten plates or similar devices onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their size, and the type of bone they are intended for. There are three sets of style: cortex, cancellous, and cannulated sets. The screw recess is hexagon or star shaped to allow screw removal and insertion. The thread diameter of screw varies from 1.5 to 7.3mm, total length from 6 to 150mm. The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The sterilization method is presented in the user manual, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.