(73 days)
The PRO-LINK Wedge and screws are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
□ Opening wedge osteotomies of Hallux Valgus
- □ Evans lengthening osteotomies
- □ Metatarsal/cuneiform arthrodesis
The PRO-LINK Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot. The implant is available in a range of sizes and footprints to suit the individual anatomical conditions of the patient. It is fabricated and manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers and titanium pins (Ti 6A1-4V ELI). The implant is hollow to permit packing with autogenous bone graft to help fusion. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the wedge to provide internal fixation. The implant also has one central threaded hole to permit the insertion of a titanium lock plate (Ti 6Al-4V ELI) to prevent screw back out.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the PRO-LINK Wedge System components with components from any other system or manufacturer. The PRO-LINK Wedge System components should never be reused under any circumstances.
This document describes the Pro-Link Wedge System, a medical device for internal bone fixation in the ankle and foot. However, the provided text does not contain the information requested in points 1 through 9 regarding acceptance criteria and a study proving the device meets those criteria.
The document is a 510(k) premarket notification summary submitted to the FDA. It details the device's intended use, materials, and technological characteristics, and presents performance data based on mechanical testing and Finite Element Analysis to demonstrate substantial equivalency to predicate devices. This type of submission focuses on showing that a new device is as safe and effective as a legally marketed predicate device, rather than providing a detailed study against specific acceptance criteria for a novel AI or diagnostic system.
Therefore, I cannot fulfill your request for the specific points because the information is not present in the provided text. The text primarily addresses regulatory submission requirements for a bone fixation system, not a study evaluating performance against acceptance criteria typically associated with AI or diagnostic devices.
§ 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.