(59 days)
The Synthes FlexNail is intended for treatment of humeral shaft fractures; specifically, it is for treatment of acute humeral shaft fractures, including certain pre- and post-isthmal fractures (including, but not limited to transverse, short oblique, long oblique, butterfly, and segmental fractures, of all grades of comminution); pathologic or impending pathologic fractures; and non- and malunions of the humeral shaft.
Synthes FlexNail is a flexible, non-reamed, locking intramedullary fixation device that is capable of sharing normal weight-bearing loads with the fixed fractured humerus. It locks within the medullary canal at either end of the bone, bridging the fracture and maintaining alignment while the fracture heals. It is available in 7.0, 7.5 and 9 mm diameters, in lengths ranging from 180 to 300 mm (in 15 mm increments). Nail accessories include: a 3.9 mm Ti Locking Bolt for nail interlocking; a Tension Screw that mates with the tension block; and End Cap Screws. The "0 mm" extension End Cap Screw is used to plug the proximal connecting thread of the nail and prevent tissue in-growth to facilitate removal. The "15 mm" extension End Cap Screw protects the proximal thread of the nail and holds the proximal extension segment to the nail. This allows the nail to be overinserted by 15 mm, while leaving the proximal end of the nail accessible for removal. The FlexNail is manufactured from a titanium alloy.
This document is a 510(k) summary for the Synthes FlexNail, an intramedullary fixation rod for humeral shaft fractures. It establishes substantial equivalence to a predicate device but does not contain any information regarding acceptance criteria or the study that proves the device meets such criteria.
Therefore, I cannot provide the requested information based on 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.