(77 days)
The Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia. Proximal humerus fractures include two-part greater tubercle fractures and fracture dislocations, two-part surgical neck fractures and fracture dislocations, three-part fractures or fracture dislocations, fractures in osteopenic bone. and nonunions and malunions. Distal tibia fractures include acute fractures, fractures in osteopenic bone, and nonunions and malunions.
The CABP is a straight plate with a blade at the head to allow for better fixation in the head of the humerus or in the distal tibia. The blade of the plate is cannulated to fit over a guide wire, allowing for the adjustment of the wire placement several times without adversely affecting the final result. There are cuts in the undersurface of the plate to reduce the surface area of the plate in contact with bone. The area of contact between the plate and the bone is decreased in an effort to reduce damage to the cortical blood supply under the plate, and resultant reduction in damageinduced porosis and remodeling of the bone near the plate undersurface. Plate undercuts also make the bending properties of the plate more uniform. which facilitate contouring. The plate has round and dynamic compression screw holes, accepts 4.5 mm and 6,5 mm screws, is available in multiple blade lengths, and is manufactured from stainless steel and commercially pure titanium.
The provided document describes a medical device, the Synthes (USA) Cannulated Angle Blade Plate (CABP) System, and its clearance process with the FDA. However, it does not contain any information about acceptance criteria, a study proving the device meets those criteria, or any performance metrics, sample sizes, expert involvement, or adjudication methods.
The document is a 510(k) submission summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device for market approval. This type of submission relies on the existing safety and efficacy data of the predicate device, rather than requiring new clinical studies with defined acceptance criteria for the new device.
Therefore, I cannot provide the requested information from the given text. The document's purpose is not to detail a performance study but to establish regulatory clearance based on equivalence.
§ 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.