GS Medical has obtained the US Food and Drug Administration (FDA) 510(k) clearance and launch of its AnyPlus T/PLIF cage, the new lumbar cage system which expands the company's successful AnyPlus platform of cages.
The company also announced FDA clearance for design modifications to its existing AnyPlus ALIF, TLIF, and PLIF interbody portfolio.
The 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 favorable union outcomes.
GS Medical executive vice president-Americas Joseph Jin said the company is 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," Jin added.
"With this recent clearance, we have one of the most extensive thoracolumbar portfolios on the market.
"We believe our AnyPlus ALIF system is a strong testament to the fact that GSM may be the only manufacturer offering this implant in heights from 10-20mm, in 1mm increments, four different footprints, with just as many lordotic options, and a bi-concave design."
The company is planning to launch new product segments, such as cervical, in Q3 and Q4 of 2014.
According to the company, AnyPlus T/PLIF and ALIF sets are currently available for limited release until full launch in June 2014.