Australia Clears Conformis’ iTotal PS Knee Replacement System

Conformis Inc’s iTotal PS System is now cleared for use in Australia.  

The global knee joint reconstruction market is projected at more than $9 billion. HCF, Australia’s largest nonprofit health insurer, reports that more than 50,000 knee replacement procedures are performed in Australia each year.

“Receiving clearance for our iTotal PS product in Australia will allow us to offer a best-in-class, patient-specific solution to relieve patients’ chronic knee joint pain,” said Mark Augusti, president and CEO. “With this clearance, we have greatly expanded the number of potential patients who will be candidates for our personalized knee replacement implants, and we are thrilled to offer the benefits of our unique technology to surgeons in Australia who prefer a posterior-stabilized design to a cruciate-retaining one.”

The company’s patient-specific iTotal PS total knee replacement system by the Therapeutic Goods Administration, which is part of the Australian Department of Health, and which authorizes the marketing of medical devices and other healthcare products in Australia.
 
The iTotal PS system, launched in the United States in 2016, is designed to address the shortcomings of traditional, off-the-shelf knee replacements that are manufactured in limited sizes and shapes. iTotal PS implants are specifically designed to restore the natural shape of each patient’s knee, and to avoid overhang, rotation, and sizing compromises associated with pain after surgery. Primary total knee implants are designed to either retain the patient’s own posterior cruciate ligament (cruciate-retaining, or CR), or substitute for it (posterior-stabilized, or PS). iTotal PS implants use a customized cam and spine feature to serve the function of the posterior cruciate ligament and to provide optimal stability throughout the full range of motion.
 
iTotal PS is designed with the following features and benefits:

• patient-specific femoral and tibial fit to avoid overhang, under-coverage, and sizing compromises;
• patient-specific shape designed to provide stability throughout the range of motion and to restore kinematics;
• patient-specific cam and spine to provide optimal stability and to reduce the potential for a “mechanical” feel;
• pre-operative surgical plan to enable a predictable, reproducible knee replacement procedure; and
• a safe and simple delivery model that includes a single pre-sterilized kit, a single reusable instrument tray, and no implant inventory.