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ConforMIS receives FDA clearance for patient-specific total knee system

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ConforMIS announced in a press release that it has received 510(k) clearance from the FDA to commercially market its iTotal CR Knee Replacement System. The company said the iTotal CR is the only true patient-specific system available for patients who would traditionally receive a standard total knee replacement.

The iTotal CR builds on ConforMIS’ patented iFit technology for generating patient-specific implants and individualized jigs. As with all ConforMIS implants, the system uses computer modeling to build a 3-D image of a patient’s knee from CT scans, the company said. That image then guides the proprietary design and manufacture of the jigs and the personalized implants that resurface the patients’ articular surfaces.

Each iTotal CR is made to fit an individual patient precisely without the under-sizing and overhang common with standard systems. The ability to maximize coverage for each patient is combined with one of the broadest implant contact areas in the industry, resulting in extremely low polyethylene contact stress, according to the press release.

The patient-specific technology of the iTotal CR preserves significantly more femoral bone than a traditional total knee replacement (TKR). The design software generates medial and lateral articulating surface geometries for each patient that more closely mimic a patient’s natural geometry while correcting for deformity, according to the press release.

“The ability to give patients a long-lasting, natural feeling knee has been the holy grail of orthopedics for decades,” Wolfgang Fitz, MD, a member of the ConforMIS surgeon design team, stated in the release. “A patient-specific total knee that reconstructs the surface geometry of the condyles has the potential to create a knee replacement that is as close to normal as it gets.”

“The iTotal 510(k) clearance marks a new phase in ConforMIS’ leadership of the patient-specific category by expanding our product line to address the full range of opportunities in the multi-billion dollar knee market, the largest segment in orthopedics,” Philipp Lang, MD, CEO of ConforMIS, stated. “In introducing the only true patient-specific total knee system, we are creating opportunities for innovation that will dramatically change the way patients and surgeons approach orthopedics.”

The commercial release version of the iTotal CR Knee Resurfacing System was 510(k) cleared in early January 2011.The iTotal system will be available in limited release to a select group of surgeons in 2011, the company noted.