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news.US-based Inbone Technologies has reported that nine surgeons from across the country have agreed to participate in a new expanded clinical study for the Inbone Fusion System that was cleared by the FDA 510(k) in July of 2005.
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The current study is intended to expand the clinical data on the accelerated fusion rates as well as show a decrease in non-unions versus traditional plates and screws.
Early results have shown an accelerated fusion rate to an average 4-8 week timeframe with non union rates at a very low 2%. The fusion time is approximately twice as fast as traditional plates and screws and approximately one-tenth of the failure rate of traditional methods.
The Inbone Fusion System provides a unique intramedullary approach to Small Bone Fusion and consists of titanium rods and plates which are surgically implanted within the bone to yield unparalleled three dimensional fixation. The porous plasma spray coating conducts bony in-growth across the implant and joint.
Dr Reiley, chief medical officer at Inbone Technologies, said: “It is encouraging to know that surgeons believe that this new technology may well improve patient outcomes significantly.”