GS Medical USA has announced that the AnyPlus T/PLIF cage has received US Food and Drug Administration (FDA) 510(k) clearance, and the US launch of the new lumbar cage system which expands the company’s successful AnyPlus platform of cages. Additionally, GS Medical announced FDA clearance for design modifications to its existing AnyPlus ALIF, TLIF, and PLIF interbody portfolio.
According to GS Medical, this next generation T/PLIF cage offers several unique features, including simple and intuitive instrumentation, tapered distal edge, superior anatomical design that facilitates ease of insertion, multiple footprints, aggressive tooth pattern, and large graft fenestrations allowing for a higher volume of bone graft to achieve favourable union outcomes.
Commenting on GS Medical’s current regulatory pathway, Joseph Jin, GS Medical’s executive vice president-Americas says, “We are pleased with this clearance as it marks the first of four additional system clearances expected in 2014. Strengthening the core thoracolumbar business in the US is one of our key initiatives. With this recent clearance, we have one of the most extensive thoracolumbar portfolios on the market.”
GS Medical USA currently has AnyPlus T/PLIF and ALIF sets available for limited release until full launch in June.