(137 days)
Synthes CFN is intended to stabilize fractures of the femur. Specifically, it is intended for acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions, and impending pathological fractures.
Synthes CFN is a cannulated locking intramedullary fixation device. It is cannulated throughout the length of the nail which facilitates insection over a guide rod into a reamed or unreamed femur. The nail has a gradual anterior bow with a radius of curvature that is designed to approximate that of the femur. It has proximal and distal locking holes that utilize the same size locking bolts. The most proximal locking hole is elongated. Nail accessories include a Twisted Blade, 5.0 mm Shaft Screws, Locking Sleeves, 4.9 mm Locking Bolts, and End Caps. The accessories are intended to transmit load between the bone and the CFN to prevent rotation and displacement of the nail/fracture when stabilizing subtrochanteric femoral fractures. The device is manufactured from titanium alloy.
This document is a 510(k) summary for a medical device (Synthes Cannulated Femoral Nail System) and describes the device itself and its equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on device description and comparison to a predicate, not on a study with acceptance criteria for device performance in a clinical or diagnostic setting.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.