(84 days)
The Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
The Synthes 2.4 mm Variable Angle LCP (VA-LCP) Two-Column Volar Distal Radius Plate is a machined metal plate that is designed for fixation of various fracture modes of the distal portion of the radius. The 2.4 mm VA-LCP Two-Column Volar Distal Radius plate allows fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. Synthes' variable angle locking technology enhances plate-screw construct stability. The plates are manufactured in either titanium or stainless steel.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets them. This document appears to be a 510(k) summary for a medical device (Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plate), which focuses on establishing substantial equivalence to a predicate device rather than detailing performance studies and acceptance criteria. The information provided is primarily regulatory in nature.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I populate the table and other requested sections.
§ 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.