(14 days)
Original indications for the Memograph® Staple System are as defined in 510(k) K993714. Additional indications fro the OSStaple" are the fixation of maxillofacial and mandibulofacial fractures and osteotomies.
The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm" has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm" gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm™ electrode and will cease if the button is released prior to the automatic cessation by the circuitry
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details that would allow me to answer your request. The document is a 510(k) summary for a medical device modification (BioWarm™) and the FDA's response letter indicating substantial equivalence to a predicate device. It discusses the device's intended use and classification but offers no data from studies or specific performance metrics.
§ 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.