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1) Bone fracture fixation 2) Osteotomy 3) Arthrodesis 4) Correction of deformity 5) Revision procedures where other devices have been unsuccessful 6) Bone reconstruction procedures

The use of External Fixation devices provides surgeons with a means of bone fixation for the management of fractures and reconstructive surgery. The Gexfix devices, in common with similar devices from other manufacturers, are intended only to assist during the healing process, and so are not intended to replace normal bone structures. The Gexfix External Fixation devices are intended use a physical mechanism of action to hold bones in positions that aid stability during healing, thus facilitating the normal healing process. Some elements of the system are implantable during the healing process, with the main structural support being provided by external mechanical elements. the predicate device, as cleared under K052605. The Gexfix range includes external fixation devices for use in a variety of orthopedic applications. They are supplied non-sterile for single use, although some accessory items can be reused. Users are instructed to sterilize the components before use, using a sterilization cycle validated to achieve a sterilization Assurance Level (SAL) of at least 10-6. The Gexfix range of external fixation devices comprises three main elements, these being: - Invasive components - . External components - Ancillary components This submission covers new components of the Gexfix system that are being added to the range of all three of the above types of component when compared with the predicate device. Some new components have an extended range of available dimensions, while other new components are additions to the range, to fulfil user needs for greater variety in the range of surgical applications, such as the introductions of components to allow external fixation of bones in the fingers, feet and shoulder. Biocompatibility of patient-contacting materials is assured by using materials that meet applicable standards (e.g. for stainless steel and titanium alloy components) or by using materials which have received previous 510(k) clearance (e.g. PEEK).