(35 days)
The Modus® Modular Distraction Osteogenesis System is a subcutaneous distractor system intended for use in fractures, osteotomies and arthrodeses including: treatment of hemifacial microsomia, mandibular hypoplasia, microglossia, defects of the alveolar ridge, atrophic bone segments in the mandible and maxilla, mandibular symphysis widening, growth disturbances of the ascending corpus/ascending ramus, and LeFort I, and LeFort II/III advancements.
The Modus plates are used with the Modus Distraction Cylinders for various applications of the maxillofacial bone structures. The Modus plates are offered in a variety of sizes and are designed to fit the anatomy of the mandible and/or maxilla and allow adjustment of the vector by intra-operative bending if indicated. The Modus Distraction Cylinders are used with the Modus plates and screws for gradual bone distraction osteogenesis and for corrective osteotomies of the mandible and maxilla. The Modus distraction cylinders are available in uni-directional or bi-directional with multiple distraction lengths. Flexible extensions are to be used with distraction cylinders if needed. The extensions allow additional access for distraction of the surgical site. The implant plates and ARS distractors are made of CP titanium Grade 4 and comply with ASTM F 67 standards for unalloyed titanium for surgical implant applications. The MDO distraction cylinders and flexible extensions are made of implant steel that complies with ASTM F 138 or ASTM F 139.
The provided text is a 510(k) summary for the "Modus® Modular Distraction Osteogenesis System," a medical device for bone distraction. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it refer to an AI component or software.
Therefore, I cannot provide the requested information. The entire 510(k) summary focuses on administrative information, device description, materials, and substantial equivalence to predicate devices, which is a regulatory pathway for medical devices. There is no mention of performance studies, test sets, experts, or AI.
§ 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.