ConforMIS's patient-specific knee replacement system cleared by FDA
This article was originally published in Clinica
Executive Summary
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.