Orthopedics devices maker ConforMIS released the latest iteration of its iTotal G2 total knee replacement system, the only such device on the market today, according to the company.
The G2 represents a years’ worth of surgeon feedback on the original design, which the FDA cleared in January 2011 and was released to a limited group of surgeons a few months later, according to a press release.
The ConforMIS total knee implants, designed for patients with knee damage from conditions such as osteoarthritis, are individually built using 3-dimensional CT scans of the patient’s knee. Software corrects for deformities caused by joint damage and the implants are manufactured at the company’s Massachusetts facility and shipped to the site of the surgery.
The new design includes updates means to address a great range of anatomies, as well as provide more streamlined surgical systems, according to the company.
"Our technology preserves more of a patient’s natural anatomy and their individual shape than is possible with off-the-shelf systems," ConforMIS CEO Dr. Philipp Lang said in prepared remarks. "The fact that the implants are personalized, not just the instruments, is what provides the iTotal G2 with clinical advantages that other systems will not be able to replicate."
The iTotal devices are the only patient-specific total knee implants on the market today, the company added.
Early this year rival orthopedics device maker and Johnson & Johnson (NYSE:JNJ) (NYSE:JNJ) subsidiary DePuy Orthopaedics cut production for all of its custom-fitted devices in response to an FDA warning following an inspection of the Warsaw, Ind.-based company’s facilities.
The watchdog agency had detailed more than a dozen devices or device components it said lacked proper PMA clearance or which were modified in ways that merit a new 510(k) application.