(34 days)
The Arthrex Fracture Plates are intended to be used for internal bone froctures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.
The Arthrex Low Profile Screws (2.0-2.4mm solid) are intended to be used as stand-alone bone screws, or in a plate screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates.
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-olone bone screws for internal bone fixation for bone froctures, fusions, ostectomies, and non-unions in the ankle, foot, hand, and wrist.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, alecranon, hymerus, radius, ulno, tibig, colconeous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Smoll Fragment Plates, distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clovicle, scapula, olecranon, humerus, radius, ulna, tibia, calconeous, femur, and fibula.
The Arthrex Fracture Plates and Screws are a family of titanium and stainless steel plates and screws. The plates are flat and contoured, ranging from 50mm to 244mm in length. The accompanying screws are 2.0mm to 6.7mm in diameter.
The provided document is a 510(k) premarket notification for Arthrex Fracture Plates and Screws. It describes a medical device, not a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria and study data for an AI/ML device is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices for bone fixation plates and screws, including proposed sterilization methods and line extensions.
§ 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.