ConforMIS Announces FDA 510(k) Clearance for iTotal Hip System

ConforMIS Inc., a medical technology company that offers knee replacement implants customized to fit each patient’s unique anatomy, has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its primary iTotal Hip replacement system.
 
“Having treated over 50,000 patients with customized knee replacement implants, ConforMIS brings over a decade of experience in patient-specific technology to the hip replacement market,” said Mark Augusti, CEO and president of ConforMIS. “FDA clearance of iTotal Hip demonstrates the ability to apply our proprietary iFit 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.
 
“Standard hip replacement surgery can be challenging, presenting risks of dislocation, discrepancies in leg length and limited reproducibility,” said Scott Ball, M.D., Department of Orthopaedic Surgery, University of California, San Diego, and a member of the iTotal Hip design team.  “With the ability to achieve a better match to a patient’s own anatomy, the iTotal Hip system aims to address these shortcomings and improve patient outcomes.”
 
“We expect to leverage synergies with sales representatives, surgeons and hospitals upon limited launch, which is anticipated for 2019,” added Augusti.  “We are excited about the opportunity iTotal Hip represents in expanding our product portfolio to address a broader orthopedic market with our proprietary technology.”
 
In the United States, approximately 400,000 hip replacements were performed in 2016. The global hip joint reconstruction market is projected at over $6 billion. 
 
ConforMIS uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.