GSA Medical Launches AnyPlus T/PLIF Cage

GS Medical USA LLC has received U.S. Food andDrug Administration (FDA) approval for its AnyPlus T/PLIFCage, and is launching the product in the United States. The FDA also cleared design modifications to GSMedical’s AnyPlus ALIF (anterior lumbar), TLIF (transforaminal lumbar), and PLIF (posterior lumbar) interbody portfolio.

The T/PLIF cage offers several 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, according to the company.

“We are pleased with this clearance as it marks the first of four additional system clearances expected in 2014,” said Joseph Jin, GS Medical’s executive vice president-Americas. “Strengthening the core thoracolumbar business in the U.S. is one of our key initiatives. 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 10-20 mm, in 1 mm increments, four different footprints, with just as many lordotic options, and a bi-concave design.”

“We are extremely optimistic about achieving our bottom line results as our regulatory and commercialization pathways look very promising for fiscal 2014,” said Jin. “We are very excited about launching new product segments, such as cervical, in Q3 and Q4, and remain hopeful for another FDA clearance before the end of Q2.”

GS Medical will officially launch the AnyPlus T/PLIF and ALIF sets in June.

GS Medical USA, LLC is a wholly owned subsidiary of GS Medical Co. Ltd., the largest South Korean spinal implant manufacturer and distributor.