Software images are part of the design process for the iTotal knee replacement.

Will the launch of a truly custom total knee replacement dramatically change the product landscape? The answer is yes, according to Philipp Lang, MD, president and CEO of ConforMIS. Today the company is announcing FDA clearance of its highly anticipated iTotal knee replacement system. The device is built on the same platform as other ConforMIS products and uses the company’s iFit software to create a patient-specific implant.

“Other than new materials, there hasn’t been much innovation in the knee market over the last 15 years,” Lang tells OrthoTec. “If you follow the implants of other manufacturers, they all look very similar and have common design features.” Standard knee implants are generally available in six or seven sizes, regardless of the patient’s size, explains Lang. Since the perimeter of the iTotal is fitted precisely to the bone, the implant will never be too small for a patient, nor will it overhang—a problem that can lead to soft tissue impingement and postoperative pain. By reestablishing the patient’s curvature (mimicking the natural anatomy), the iTotal aims to achieve normal knee function while saving a significant amount of bone too.

With its partial knee products, ConforMIS was previously in a small segment of the knee market. “Total knees are 80%+ of the market,” says Lang, so the iTotal introduces a significant opportunity for the company.

As far as the surgeon learning curve goes, Lang says it is a lot faster than a standard implant. “Most implants have 12 steps. The surgical technique that we have is highly reproducible and accurate; it only entails seven steps,” says Lang. The device will be available in the United States through a limited release to surgeons by invitation only. They will provide intraoperative feedback on the surgical technique and will train other surgeons once ConforMIS initiates its broader product launch. “[Although there are fewer] substeps than traditional total knee systems, that doesn’t change the fact that as an emerging company, we want to do an extra job in introducing surgeons to the technology,” says Lang, adding that ConforMIS is keeping the list price of the iTotal lower than competing products. The company plans to submit the iTotal for CE mark approval in a couple of months.

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