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ConforMIS receives FDA 510(k) clearance for new hip replacement system

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ConforMIS Inc. announced it has received FDA 510(k) clearance for the iTotal Hip replacement system, according to a company press release.

According to the release, the hip replacement system uses patient-specific technology, single-use 3-D printed instruments and a delivery model to create a system that needs limited reusable instruments.

“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,” Mark Augusti, chief executive officer and president of ConforMIS, said in the release. “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 toward personalized health care and we believe patients expect and deserve personalized treatment.”

He added, “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.”

Reference:

www.conformis.com