(91 days)
Synthes 3.5mm Locking Attachment Plate is intended for use with Synthes LCP plates to augment the stabilization of fractures, including periprosthetic fractures and fractures in the presence of intramedullary implants, in the femur, tibia and humerus, particularly in osteopenic bone.
The Synthes 3.5mm Locking Attachment Plates are low-profile, pre-contoured plates which are intended to be used with existing Synthes LCP plates to stabilize fractures. The plates are available in stainless steel and titanium.
The provided text is related to a 510(k) premarket notification for a medical device called "Synthes (USA) 3.5mm Locking Attachment Plates." This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.
The content is a regulatory approval letter and a summary of the device for submission to the FDA, focusing on establishing substantial equivalence for market clearance. It typically does not include raw study data or detailed performance metrics.
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§ 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.