FDA clears CT-based total knee replacement system

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ConforMIS, which develops and commercializes medical devices for osteoarthritis treatment and joint damage, has received 510(k) clearance from the FDA to market its iTotal CR Knee Replacement System.

The system uses computer modeling to build a 3D image of a patient's knee from CT scans, according to Burlington, Mass.-based ConforMIS. That image then guides the design and manufacture of the jigs and personalized implants that resurface patients' articular surfaces.

The design software generates medial and lateral articulating surface geometries that mimic a patient's natural geometry while correcting for deformity, the company said.