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The GenerOs SB is an implantable device for distraction osteogenesis techniques in the small bone of the extremities. GenerOs SB is used to treat conditions where small bones of the extremities are deficient. The types of deformities that fall into this category include, but are not limited to: - Congenital deficiencies of the bones of the forearms, wrists, ankles, hands and feet; - Post-traumatic deficiencies of the bones of the forearms, wrists, ankles, hands and feet: - Deficiencies of the bones of the forearms, wrists, ankles, hands and feet due to tumor resection. Each GenerOs SB is intended for single use only. The device is to be removed after distraction and bone stabilization are complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. The device is not intended to be fixed to the bone with bone cement. However, it is possible that commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface.

GenerOs SB is an implantable device made of surgical grade stainless steel for deficiencies of small bones of the extremities. It features two telescoping component bone plates that are distracted apart by a threaded drive shaft. The activation pin and the drive shaft are articulated using an internal gear. The device has a fixation plates on the activation and sliding block, and if not used for fixation of the device, may be easily removed. Activation of the drive shaft occurs through a transcutaneous pin. which is removed once the distraction phase is complete. The GenerOs SB implant is removed after distraction and consolidation are complete. The GenerOs SB includes reusable instruments such as activation, insertion / removal tools and other surgical instruments. GenerOs SB is a single-use device, sold non-sterile, and requires sterilization prior to use. It is. Sterilization instructions are included in the labeling.