OMNIlife science, Inc. has received FDA clearance for its Apex PS Knee.
OMNIlife is a subsidiary of Orthopaedic Synergy, Inc. a company led by former Johnson & Johnson knee employees, formed in late 2008 as a holding company for joint venture partners, Enztec, Ltd. of New Zealand, Praxim, SA of France and U.S.-based OMNIlife science.
The PS knee was introduced into the European market at the end of 2010, with a full U.S. launch expected by the end of 2011.
A company announcement on July 5 said the PS "maintains the key design elements of the existing Apex Cruciate Retaining (CR) Knee but offers the post and cam system preferred by surgeons who utilize a posterior stabilized knee replacement." The company believes the design allows the device to have up to an additional 30° of uninterrupted patella track compared to competitive posterior stabilized knee designs that require a larger bone resection.
"The extra patella track potentially reduces the chance of experiencing a problem that has been associated with knee replacements known as patella 'clunk'. A single step reaming process allows a seamless intraoperative transition from a CR Knee to a PS Knee based on surgeon preference. By taking advantage of the intercondylar fossa for the location of the Apex PS Knees’ 'box' cut, there is as much as a 90% reduction in the bone removed compared to some competitive PS knee designs," stated the company announcement.
George Cipolletti, the company's CEO and former Manager, Knee Research at Johnson & Johnson, said, “We believe that the design of the Apex PS Knee will set a new standard in the orthopedic industry that will benefit both patients and surgeons.”
Anthony F. Infante, Jr., D.O. said, “I really enjoy using the instruments for the Apex PS knee; it’s certainly the easiest and most repeatable box cut that I have ever made. In the past, I’ve typically used an ultra congruent insert for posterior stabilization because of the amount of bone that was removed in a typical PS Knee. With the OMNI system, the amount of additional bone that is removed is so insignificant I have no problem using this PS Knee in all of my patients.”
Cipolletti's claim is bold. Now surgeons and patients will have a chance to prove him right or wrong.