FDA Clears OMNIlife science’s Robotic Tissue Balancing Device

OMNIlife science Inc., a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced that the FDA has issued 510(k) clearance for its proprietary robotic tissue balancing device which is used with OMNI’s market-leading OMNIBotics robotic-assisted total knee replacement technology platform.
 
This new technology, in clinical use since March in Australia, provides the surgeon with a quantitative tool to actively manage the soft tissue envelope with dynamic real-time feedback. When combined with the accuracy of alignment and bone cuts provided by the OMNIBotics system, the result is a completely customized procedure from both a skeletal perspective as well as a soft tissue perspective.
 
“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,” said Guy Mayer, Executive Chairman of OMNI’s Board of Directors. “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.”
 
The OMNIBotics system enables optimized knee implant placement using robotics driven by OMNI’s proprietary ART software. With more than 16,000 OMNIBotics procedures performed to date worldwide, it eliminates the need for preoperative CT scans or x-rays. Intraoperative adjustments are easily made, and the precise alignment of the implant may lead to a more rapid recovery and a more natural feeling total knee replacement.^1,2
 
“This is a major milestone for both OMNI and for the orthopedic market,” stated Christian Joly, vice president of robotics at OMNI. “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.”
 
References
¹Koenig JA, Suero EM, Plaskos C: Surgical Accuracy and Efficiency of Computer-Navigated TKA with a Robotic Cutting Guide – Report on First 100 Cases. J Bone Joint Surg Br 2012 vol 94-B no. SUPP XLIV 103. 
²Revenga C, et al, Computer-Assisted Navigation Versus Conventional Total Knee Arthroplasty In A Spanish Multicenter Study. 16th EFORT Congress. London. 2014.