ConforMIS announces FDA clearance for iTotal Hip replacement system
ConforMIS announced it has received FDA 510(k) clearance of the company's primary iTotal Hip replacement system. Mark Augusti, CEO and president of ConforMIS said, "FDA clearance of iTotal Hip demonstrates the ability to apply our proprietary iFit(R) image-to-implant technology to other joints. There has been a trend towards personalized healthcare and we believe patients expect and deserve personalized treatment." The ConforMIS iTotal Hip system features proprietary iFit technology similar to that used to design, manufacture and deliver customized knee implants. The system utilizes ConforMIS's patient-specific technology, single-use 3D printed instruments and just-in-time delivery model to create a system that requires limited reusable instruments. "We expect to leverage synergies with sales representatives, surgeons and hospitals upon limited launch, which is anticipated for 2019," added Augusti.