(31 days)
The Titanium-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
Not Found
This document is a 510(k) summary for the Titanium-Hip ToolTM. It indicates that the device is substantially equivalent to a previously cleared predicate device (Hip Tool™ Implant, K022139) and describes its intended use. However, it does not contain any information about acceptance criteria, performance studies, or clinical data that would typically be used to prove a device meets such criteria.
Therefore, I cannot provide the requested table and information based on the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed 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.