(67 days)
The Small Fragment System consists of bone plates and screws to be used for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, toes, and craniomaxillofacial skeleton.
The Lorenz Small Fragment System is comprised of a variety of titanium plates and screws with shapes and sizes designed for internal fixation of small bones. The screws will have both cross drive and center drive head features and be 1.2mm - 2.7mm in diameter. The plates will include straight, rectangle, parallelogram, trapezoid, T, L, Y, Z, and condylar pin options with various lengths and thicknesses.
This document is a 510(k) summary for the Lorenz Small Fragment System, a medical device. It describes the device, its intended use, and potential adverse effects. It also includes the FDA's clearance letter, stating the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, or any study details that would prove a device meets acceptance criteria.
Therefore, I cannot fulfill your request for the specific points about acceptance criteria and a study demonstrating compliance. The submission document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with specific metrics.
§ 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.