(240 days)
IFS bone plates and screws, provided non-sterile, are intended to treat fractures and osteotomies of various bones including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, calcaneus, and fibula.
The IFS washers, provided non-sterile, are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over an area when used for fracture fixation of small bones and bone fragments.
IFS bone plates consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones, including the clavicle, pelvis, scapula, humerus, radius, ulna, femur, tibia, and fibula. The washers are to function with screws to prevent the screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates, screws, and washers are a one-piece device made of Titanium 6Al-4V ELI or stainless steel.
This document is a 510(k) summary for Internal Fixation Systems, Inc.'s IFS Bone Plates, Screws, and Washers. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices.
This document is a 510(k) premarket notification summary and does NOT contain information about acceptance criteria or a study proving device performance against such criteria. It's a regulatory submission to demonstrate equivalence to already-marketed devices, not a performance study report.
Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory equivalence rather than performance metrics.
§ 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.