ConforMIS (NSDQ:CFMS) said today it won FDA 510(k) clearance for its primary iTotal Hip replacement system.
The iTotal Hip system features the company’s iFit technology which uses single-use, custom 3D printed instruments and a limited amount of reusable instruments to deliver a customized hip replacement, the Billerica, Mass.-based company said.
“Standard hip replacement surgery can be challenging, presenting risks of dislocation, discrepancies in leg length and limited reproducibility. 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,” iTotal Hip design team member Dr. Scott Ball of the University of California, San Diego said in a prepared statement.
ConforMIS said that in the US, there were approximately 400,000 hip replacements last year, and that the global hip joint reconstruction market is projected to be over $6 billion.
“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. 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. We expect to leverage synergies with sales representatives, surgeons and hospitals upon limited launch, which is anticipated for 2019. We are excited about the opportunity iTotal Hip represents in expanding our product portfolio to address a broader orthopedic market with our proprietary technology,” prez & CEO Mark Augusti said in a press release.
In April, ConforMIS said that a head-to-head study comparing its iTotal PS customized knee implant with the off-the-shelf NexGen PS implant made by Zimmer Biomet (NYSE:ZBH) showed that its device more closely replicated the natural motion of a human knee.
