(77 days)
The Osteonics® FX-Cablelok™ Grip Components are indicated for trochanteric reattachment and are intended for use with the commercially available Osteonics® FX-Cablelok™ System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.
The subject devices are characterized by the following design features: Staple like grip design with proximal and distal hooks used in conjunction with trochanteric cable and crimp sleeves.
The provided text is a 510(k) Premarket Notification for the Osteonics® FX-Cablelok™ Grip Components. This document establishes substantial equivalence to previously marketed devices and does not contain information about acceptance criteria, a standalone study proving performance, sample sizes for test/training sets, or specific details on ground truth establishment or expert involvement in a study.
Therefore, I cannot provide the requested information as the provided text does not describe a study that proves the device meets acceptance criteria. The document focuses on regulatory approval based on demonstrating equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.
§ 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.