(89 days)
To provide interference fixation of bone-tendon-bone and soft tissue-grafts in ACL reconstruction through arthroscopy or arthrotorry.
The Arthrex Bio-Interference Screw is a bioabsorbable interference screw used to fix a graft to a bone in ACL reconstruction. It is inserted between the tunnel wall and graft to hold the graft in place. It is implanted with accessories such as a screw sheath, driver, guide wire, dilator, notcher, tap, and remover.
This 510(k) summary (K971358) for the Arthrex Bio-Interference Screw does not contain any information about acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information. The document details the device's functionality, technological characteristics, and intended use, comparing it to a previously cleared Bio-Interference Screw from Arthrex and Linvatec's BioScrew, to argue that it raises no new issues of safety or effectiveness. There is no mention of clinical studies, performance metrics, sample sizes, expert involvement, or ground truth establishment.
§ 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.