(50 days)
The Orthofix MIOT Plating System is intended for non-load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures and reconstruction.
The Orthofix MIOT plating system consists of bone plates made of stainless steel The Oftholix MIOT plaining cyclom small bone fragments. They are anatomically designed for the internamized fragment adapted approach. If necessary, they precontoured and allow a casternization in the sare available in different shapes Can be bent to doquire the doch on a left and a right configuration and come in (Straight, C =, 1 - and oblique - onaps), in a levening stainless steel FFS wires. Plates umerent sizes. They are attached to FFS wires, depending upon its shape and size. can accommodule throughts for the insertion and removal of the plates.
The provided 510(k) summary for the Orthofix MIOT Plating System (K051945) does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria.
This document is a "Substantial Equivalence" determination, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves comparing design, materials, and intended use, rather than conducting a new performance study with acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence, not on a performance study with defined 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.