ConforMIS's patient-specific knee replacement system cleared by FDA
This article was originally published in Clinica
ConforMIS's iTotal CR knee replacement system, which the company claims is the only true patient-specific device of its kind, has received 510(k) clearance from the US FDA. The firm uses a computer modelling system to build a 3D image of a patient's knee from CT scans, which guides the design and manufacture of patient-specific jigs and personalised implants. The process is carried out using ConforMIS's patented iFit technology. This means the implant fits the patient precisely, without the under-sizing and overhang common with standard devices, the Burlington, Massachusetts-based company claims. It will make the device available to a "select group of surgeons" this year.
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