Implants designed for repair of large fracture fragments usually require a metal plate or rod and multiple screws to adequately fixate the fracture. Fractures in and around joints are difficult to treat with current solutions and fixation locations in the metal plates and rods are limited and predefined.
In total, there are roughly 40.000 patients a year in the Netherlands alone in need of surgery for their bone fracture in either upper or lower extremities. All of them could benefit from more versatile and simpler fixation by ultrasonic welding, however the particularly complex fractures that do not have optimal fixation solutions available, would benefit most from this solution.
Bonutti Technologies has come up with OsteoWeld, an ultrasonic welding system that uses high frequency vibratory energy to intracorporeally weld polymer-based screws and other fixtures quickly and safely to bone or metal implants. OsteoWeld’s ultrasonically weldable nails and tacks allow for nearly infinite fixation locations as well as reduced procedure time and x-ray exposure. The welding hand piece is a simple handheld device that uses a feedback algorithm to signal when welding is complete. The solution can be used on its own to fix commonly used plates and rods or in combination with another Bonutti product, Transet, for fixation of complicated fractures using a combined anchor and repositioning clamp solution.
A working prototype including feedback algorithm for the ultrasonic welding has been developed. Both PEEK and PLLA implants for use with the system have received 510(k) clearance for use in Trauma and Sports Medicine. The generator and hand pieces have been evaluated to the IEC60601-1 electrical safety standard. What remains to be done is to further test clinical efficacy of the solution.