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OMNIlife science receives FDA 510(k) clearance for robotic TKR tissue balancing device
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OMNIlife science Inc. has announced that the FDA issued 510(k) clearance for its proprietary Active Spacer robotic tissue balancing device, which is used with the company’s OMNIBotics robotic-assisted total knee replacement technology platform.
The new technology, which has been in use in Australia since March, is a quantitative tool for total knee replacement (TKR) to actively manage the soft tissue envelope with dynamic real-time feedback. When combined the OMNIBotics system, which provides accurate alignment and bone cuts, TKR becomes a completely customized procedure from a skeletal, as well as a soft tissue perspective, according to a company press release.
“Our proprietary Active Spacer technology represents a unique and significant step in the development of our OMNIBotics robotic platform. We have been convinced that a perfect knee alignment is not enough to enable good outcomes for our surgeons and their patients,” Guy Mayer, executive chairman of the OMNI Board of Directors, said in the release. “We believe that our surgeons can now perform the perfect total knee replacement with our innovative robotic soft tissue balancing technology coupled with the optimum knee alignment provided by our OMNIBotics technology.”
“This is a major milestone for both OMNI and for the orthopedic market,” Christian Joly, vice president of robotics at OMNI, said. “We are now the only company in the world to provide a robotic technology to quantitatively drive the total knee replacement surgical procedure with both alignment and ligament balancing.”