Singapore, Aug 26, 2010: South Korean medical devices company, Medyssey, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Zenius Thoracolumbar Spinal System. Though currently available in limited release, Medyssey will launch the new Zenius System in the United States in Q4.

The Zenius System is a Ti alloy 5.5 mm Rod and Thoracolumbar Pedicle Screw Construct for the surgical treatment of spinal trauma, deformity, and degenerative spinal pathologies. Zenius utilizes a Dove Tail Joint Set Screw, with patent-pending reverse trapezoid thread design and linear slot, to dramatically increase holding forces over a traditional (non-slotted) set screw.

"The clearance of the Zenius Spinal System rounds out our company's spinal instrumentation portfolio of Thoracolumbar PSF solutions in 5.5, 6.0 and 6.35 mm Rod Constructs through the Zenius and Novel systems," said Mr Joseph Jin, VP, Medyssey Spine."Medyssey is now investing into building out the orthobiologics and interbody platforms to support our core fusion, dynamic stabilization, and motion preservation systems."