The newly cleared screw systems are designed for use with DePuy Synthes’ Confidence high viscosity spinal cement, and can be used in either open or percutaneous spinal fusion surgeries.
The Viper and Expedium screw systems are designed with a hollow shaft and fenestrations above the screw tip to allow for spinal cement delivery into the vertebra for immediate screw fixation. The Viper screws are compatible with Viper and Expedium 5.5 spine systems, and Expedium screws are compatible with the Expedium Verse spinal system, DePuy Synthes said.
“Metastatic disease in the spine can be severely painful and limiting for patients who are really trying to maintain quality of life, and there is a significant need for spinal implants that enhance stability in metastatic bone disease so that these patients can continue to function freely. We designed these fenestrated screw systems to help address those needs, and to facilitate minimally invasive solutions for patients suffering from this disease,” DePuy Synthes Spine R&D VP Dr. William Horton said in a prepared statement.
The company said it hopes to make the newly cleared pedicle screws available in mid-2017.
Earlier this month, Johnson & Johnson said it is recalling its DePuy Synthes radial head prosthesis because of the risk of loosening in the component that anchors the implant in the arm’s radius bone.
The entire prosthesis is designed for primary and revision replacement of the radial head, but only the radial stem surgeons insert into the radius is involved in the loosening issue, according to a letter the J&J unit sent to physicians Dec. 30, 2016.
The post DePuy Synthes wins FDA nod for Viper, Expedium pedicle screw systems appeared first on MassDevice.
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