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The Newfix® External Fixation System, consisting of axial fixators and frame components, is indicated for stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: open fractures, closed fractures, poly-trauma fractures, supplement in the stabilization of minimal fixations in intra and extra articular fractures. The Newfix® External Fixation System lengthening components (rail systems) are unilateral external fixation devices and components intended for use in adults and pediatrics in the treatment of bone conditions including leg lengthening (osteotomies), arthrodesis, fracture fixation, and other bone conditions amendable to treatment by use of the external fixation modality.

The Tecnología y Diseño Industrial, S.A. de C.V. Newfix® External Fixation System consists of various components including fixators, clamps, bars, distractors, carbon fiber rod, and stainless steel rods for use in orthopedic and trauma treatments. TDI's Newfix® External Fixation System (Newfix External Fixation System 4.1 k101338 and Newfix Screws, Wires and Pins k101254 and this submission under review) consists of bone screws, pins and wires and external fixation components and lengthening systems. The System is utilized in the following manner: bone screws are inserted through the patient's skin and soft fissue and into the bone. The fixator frame of the Newfix® External Fixation System is attached to the shanks of the bone screws. The intended use and product technology of this submission have not changed from the earlier cleared submissions. The present submission adds axial and pelvic fixation devices (including radiolucent wrist fixator), straight and angled clamps and rail lengthening transport systems. The Newfix® External Fixation System is supplied non sterile and is intended for single patient use. None of the components of the Newfix System are reusable. The Newfix® External Fixation System includes instruments and accessory devices necessary for its use.

The Newfix Screw, Wire and Pin Fixation System is to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants.

The Newfix® Screw, Wire and Pin Fixation System is a family of threaded external fixator of various sizes for use in the treatment of fractures. Pins include smooth and self drilling/self-tapping type threaded pin with diamond tip and cutting edges. The pin and screws of the Newfix System are manufactured using implant grade stainless steel. Pin configurations include Kirschner Pins (K-wires), Schanz Screws, Steinmann Pin and Conic Threaded Bone Screws all in various lengths, diameters and threads. The Newfix® Screw, Wire and Pin Fixation System is intended for single patient use. None of the components of the Newfix System are reusable. The Newfix® Screw, Wire and Pin Fixation System includes the following accessory devices: Depth Gauge; Tissue Protection Triple Guide for Axial Fixation; T Shape Handle Chuck; and Drill Bits.