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Home » DePuy lands 510(k) for knee implant customization system | Regulatory Roundup

DePuy lands 510(k) for knee implant customization system | Regulatory Roundup

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DePuy

DePuy Orthopaedics Inc. landed clearance for its TruMatch surgical customization system for use with its Sigma fixed-bearing knee replacement device.

That means the Warsaw, Ind.-based Johnson & Johnson (NYSE:JNJ) subsidiary no longer has to worry about the FDA’s past warnings over illegal marketing of the device on its website.

"TruMatch technology helps surgeons consistently provide knee replacement patients a customized fit and enables them to do the operation in less time," Dr. Daniel Hoeffel of Summit Orthopaedic Group said in prepared remarks.

The system, which is also available in 12 other countries, uses CT scans and computer software to guide development and production of cutting blocks that are customized to match a patient’s actual bone surfaces. TruMatch can cut time surgery time and eliminates up to nine steps in the knee replacement surgery process, according to a press release.

 The FDA warned the company about advertising the system on its website in August 2010, saying it lacked clearance or approval to market its TruMatch Personalized Solutions System in the U.S.

DePuy is still mired in lawsuits concerning its Pinnacle metal-on-metal hip implant over findings that they shed minute metal particles into a patient’s bloodstream as the hip’s ball joint wears on the metal cup.

Regulatory Roundup

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  • WideMed lands CE Mark for mobile sleep apnea monitor

    Israel-based WideMed Ltd. won CE Mark approval for its Morpheus Ox mobile sleep apnea monitor for home use. The device can monitor, measure and analyze snores and send data to a physician.

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