(375 days)
The Porex Fixation System for maxillofacial surgery is intended for rigid fixation in the repair of maxillofacial fractures and in maxillofacial reconstruction. The Porex Fixation System For Maxillofacial Surgery is intended for single use.
The Porex Fixation System is a plate and screw system to be used in maxillofacial surgery and is provided in various configurations. The components that comprise the systems are composed of unalloyed titanium plates, titanium alloy bone screws and surgical stainless steel instruments for the installation of the screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 standard. The screws are manufactured of 6-4 ELI titanium that meets the A.S.T.M F136 standard. The screws are provided in 1.5mm diameter and 4mm length. The rescue screws are green color annodized and provided in 1.8mm diameter and 4mm length. The Porex Fixation Systems are sterilized by ethylene oxide sterilization.
The provided document is a 510(k) summary for the Porex Fixation System for Maxillofacial Surgery. It details the device description, indications for use, and a statement of substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory approval based on substantial equivalence rather than presenting performance study results or acceptance criteria for a new device.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.