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The Device
GenerOs SB is a close cousin of the GenerOs CF device and is covered by the same patent (US patent 5,364,396). It was cleared for commercial use by the FDA in August 2005.
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The GenerOs SB Device |
| GenerOs SB is used to treat conditions where small bones of the extremities are deficient. The types of deformities that fall into this category include, but are not limited to: |
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Congenital deficiencies of the bones of the forearms, wrists, ankles, hands and feet; |
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Post-traumatic deficiencies of the bones of the forearms, wrists, ankles, hands and feet;
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Deficiencies of the bones of the forearms, wrists, ankles, hands and feet due to tumor resection.
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The application of GenerOs SB for distraction osteogenesis in correction of small bone deficiencies is often performed in lieu of bone grafting to augment deficient bone. The advantages of distraction osteogenesis include:
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Sparing the patient the morbidity, including potential for adverse scarring, infection and deformity (especially in children), that results from surgery at distant sites when bone grafts are harvested; |
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Gradual adjacent soft tissue adaptation over time, thus minimizing the potential for tissue necrosis, nerve or vessel injury, and relapse associated with bone graft resorption.
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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.
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How It's Used
GenerOs SB 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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Typical placement of GenerOs SB to lengthen a deficient forearm bone. Inset shows Activation Tool engaging Activation Pin |
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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 brief outpatient procedure. GenerOs SB will distract up to 20 millimeters, which is adequate for 90% of cases.
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X-ray of correction of a 17.3mm deficiency in a child’s ulna with GenerOs SB. Device shown during bone consolidation phase. Activation Pin removed.
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GenerOs SB Benefits
There are some important benefits of GenerOs SB 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 for a myriad of osteoplastic surgery needs. Its malleable break-off plates make it fast and simple for the surgeon to insert and form to bony contours. Its removable, low profile Activation Pin is unobtrusive and leaves minimal scar.
GenerOs SB is supplied to physicians qualified to treat disorders and deformities of the hands, wrists, feet, ankles, and pediatric limbs.
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GenerOs SB: 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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