(65 days)
The Inter-Os Bone Generator™ is an implantable device for distraction osteogenesis techniques in the facial bones implanted by a surgeon. Distraction osteogenesis involves making an osteotomy through the bone and then slowly moving the bone ends apart. The result is a stretching of the bone callus so that new bone is generated in the gap. This technique is well-established and follows the principles of Mizarov. (See Addendum A Osteogenesis Research Bibliography)
The Inter-Os Bone Generator™ is used to treat conditions where bone growth is deficient. The types of deformities that fall into this category are:
various forms of otomandibular syndrome, hemifacial microsomia, Treacher-Collins syndrome, condylar agenesis, craniosynostosis, Apert's syndrome, Crouzon's syndrome, Pfeiffer's syndrome, etc.
The application of the device is done in place of bone grafting to augment deficient areas of bone growth. The advantages of distraction bone generation are that the patient is spared the morbidity of additional surgical sites and native autogenous bone is formed. The device can also be used in post-traumatic deformities, such as condylar fractures in children.
The Bone Generator™, therefore, is intended to be used in the various bones of the craniofacial region, such as the mandible, zygoma, maxilla, frontal bone, and the temporal bone. It is not the current intended use to apply the Bone Generator™ to the long bones of the limbs or in the spine, but only to the bones of the craniofacial region.
The Bone Generator™ is intended for single use and is not meant for repeat sterilization and implantation. The device is to be removed after distraction stabilization is complete. It is to be used with other commerciallyavailable accessory devices, such as bone screws for fixation to the bone surface. The device is not meant to be fixated to the bone with bone cement, however, it is possible that commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface.
The Inter-Os Bone Generator™ is an implantable device used to treat conditions where bone growth is deficient. It is used for the distraction osteogenesis techniques in the facial bones and implanted by a plastic surgeon. The device is to be removed after distraction is complete. It features two telescoping components that are distracted apart by a threaded drive shaft. Activation of the drive shaft is by means of a transcutaneous pin which may be removed once the distraction phase is complete. The activation pin and drive shaft are articulated using an internal gear.
All of the components of the Inter-Os Bone Generator™ are fabricated from stainless steel.
The Inter-Os Bone Generator™ is intended to be sold non-sterile. Sterilization instructions are included in the labeling. It is a single-use device.
The provided text describes a medical device, the "Inter-Os Bone Generator™," and its 510(k) summary for FDA clearance. However, the document does not contain the acceptance criteria or a study outlining the device's performance against such criteria.
The document states:
"Performance has been substantiated by mechanical tests, animal studies, and In vivo patient trials which are included in the submission."
This indicates that such studies were submitted to the FDA for review, but their details, including acceptance criteria, results, sample sizes, and ground truth establishment, are not present within the provided text.
Therefore, I cannot provide the requested table and detailed information based on the given input. The provided text only summarizes the device, its intended use, and indicates that performance data was submitted, not the data itself.
§ 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.