ConforMIS, Inc. has had an FDA cleared customized knee replacement system for over a decade. On June 14, 2017, the FDA granted the company 510(k) clearance to market its primary iTotal Hip system.
FDA Clears Customized Hip System
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According to a June 20, 2017 company press release, 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.
The company has been in competition with customized knee devices from larger implant makers like Zimmer Biomet Holdings, Inc. 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 showed that its device more closely replicated the natural motion of a human knee.
Scott Ball, M.D., of the University of California, San Diego and design team member, 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.”
Company President and CEO Mark Augusti said over 50,000 patients have been treated 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.”
The company says there were over 400,000 hip replacements in the U.S. in 2016 and the global hip replacement market will soon reach over $6 billion.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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