The FDA gave 501(k) clearance for a robotic tissue balancing device from OMNIlife science, which works with its OMNIBotics robotic-assisted knee replacement technology to provide a more custom procedure.
The tool monitors the soft tissue envelope during an operation and provides feedback to the surgeon in real time. Using it in coordination with the OMNIBotics Bone Morphing technology — which creates a 3D image of a patient’s anatomy surgeons refer to when cutting bone and positioning an implant — surgeons can more accurately complete a knee replacement operation that is better customized based on the patient’s alignment and biology.
“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,” board executive chairman Guy Mayer said in a press 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.”
Designed to relieve joint pain and degeneration, the OMNIBotics system performs total knee replacements and allows surgeons to thoroughly plan and carry out the procedure. It allows patients to avoid CT scans or x-rays before their surgery and promotes quicker recovery. More than 16,000 operations using OMNIBotics have been completed to date.
Before OMNI’s announcement yesterday, the tissue balancing technology had been in clinical use in Australia since March.
“This is a major milestone for both OMNI and for the orthopedic market,” vice president of robotics Christian Joly said in the statement. “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.”