GS Medical USA, LLC, (GSM) a global manufacturer and supplier of spinal implants, instrumentation, and developer of innovative surgical solutions, has announced that the AnyPlus® T/PLIF Cage has received U.S. 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, GSM announced FDA clearance for design modifications to its existing AnyPlus® ALIF, TLIF, and PLIF interbody portfolio.
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 favorable union outcomes.
Commenting on GSM's current regulatory pathway, Joseph Jin, GS Medical's Executive Vice President-Americas said, "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. 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."
"We are extremely optimistic about achieving our bottom line results as our regulatory and commercialization pathways look very promising for fiscal 2014," said Mr. 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," added Mr. Jin. "GS Medical is poised for growth under new leadership, and we are honored to be afforded the opportunity to unveil the new GS Medical USA portfolio to our distributor partners and surgeon end-users."
Mr. Jin noted that GS Medical USA currently has AnyPlus® T/PLIF and ALIF sets available for limited release until full launch in June.