The Device
GenerOs CF is a small, proprietary (US patent 5,364,396) device that enables distraction of the bones of the face and skull to correct developmental, congenital, and acquired defects and deficiencies. The device is made of surgical grade stainless steel with an internal gear system that allows for activation to take place even though the device is buried below the skin and soft tissues. The device is often implanted through incisions inside the mouth, thus minimizing external surgical scars. |
The GenerOs™ CF Device |
How It's Used
GenerOs CF has two blocks that are fixed to the bone on either side of the bone cut with readily available 1.5 mm – 2.0 mm miniscrews. During the Activation Phase a small transcutaneous activation pin is turned which drives a mechanism to separate the two blocks. As the two blocks are separated the bone gap is increased. The thread pitch on the activation screw is set so one complete turn equals 0.25 millimeters. Therefore, to distract 10 millimeters for example, the activation pin must be turned four times per day for 10 days.
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At the end of the Activation Phase the Activation Pin is removed and the device is left in position on the bone until the bone is completely calcified (Consolidation Phase). The device is then removed in a small outpatient procedure. GenerOs CF will distract up to 20 millimeters, which is adequate for 95% of cases.
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GenerOs CF Benefits
There are some important benefits of GenerOs CF compared to competitive devices now available. It is small and adaptable to the bone, making it easy for the surgeon to use on patients of all ages and osteoplastic surgery needs. It is inserted through the mouth for lower jaw applications and can be positioned for virtually any distraction vector required. Its break-off plates make it fast and simple for the surgeon to insert and its removable, low profile activation pin is unobtrusive and leaves minimal scar.
Dozens of GenerOs CF devices have been used successfully to treat patients with a variety of craniofacial conditions, resulting in FDA approval of the device for widespread use. GenerOs CF is supplied to physicians qualified to treat disorders and deformities of the craniofacial skeleton. |
GenerOs CF: Features and Benefits |
| Feature |
Benefit |
| Implantable |
Less external scarring |
| Activation Pin 90° to distraction plane |
Infinite vector control |
| Multiple, adaptable fixation points |
Custom modifiable to anatomic demands |
| 20mm distraction potential |
Avoids bone grafting; excellent soft tissue adaptation |
| Easy Activation Pin removal |
Complete external healing during bone consolidation |
| Compact, yet strong |
Infants to adults |
| Patient-Doctor support program |
Saves time; fosters compliance; reduces risk |
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