(59 days)
Cases of fracture of the long leg bones are not uncommon and are usually caused by trauma. The surgical re-construction of either the tibia or femur is necessary to restore the patient back their natural alignment and gait. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections in alignment until natural healing occurs. The nails creates a sound foundation for the partial, then when healed full load bearing.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Omni-Fix, Nail System." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means the FDA determined the new device is as safe and effective as a legally marketed predicate device, rather than requiring the submission of a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot extract the requested information from the provided text.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.