(91 days)
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
The CrossRoads Screw System was previously cleared under 510(k)s K143039 & K152072 and is comprised of bone screws having various features in a variety of diameters and lengths to accommodate differing patient anatomy. The screws that are the subject of this submission incorporate design modifications and additional lengths to the 2.0mm, 2.5mm, and 3.0mm screws as well as the addition of new 2.0mm, 4.0mm and 7.0mm Headless Screws. The design modifications include screw thread changes, screw head/driver interface changes, and the addition of reverse cutting threads.
This document describes a 510(k) premarket notification for the CrossRoads Screw System. It indicates that the device has been found substantially equivalent to previously cleared predicate devices.
However, the provided text does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical effectiveness studies (MRMC or standalone).
The "Performance Testing" section states: "Engineering analysis was performed utilizing the worst-case sizes the subject CrossRoads Screw System. This analysis showed the subject device to be substantially equivalent in terms of performance to the predicate CrossRoads Screw System (K152072 and K143039). Thus, it was determined that no additional mechanical testing is required."
This implies that the device's substantial equivalence was established through an engineering analysis comparing it to existing predicate devices, rather than through new clinical studies demonstrating specific performance metrics against defined acceptance criteria. Therefore, most of your requested information is not present in this document.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.