Medyssey’s LP Cage Receives 510(k) Approval

Medyssey Co., Ltd. has announced that Medyssey Spine has received 510(k) clearance from the U.S. Food and Drug Administration for its LP Cage device. The LP Cage is used in adult patients with degenerative disc disease at one or two contiguous levels from L2-S1. The company currently is selling the product in selected markets; executives have scheduled a full commercial launch for the last quarter of 2011.

“Given the challenging regulatory climate, we are extremely pleased to obtain clearance, and we are eager to introduce, market and sell the first of many cages of what will ultimately be a portfolio of interbody fusion systems,” Joseph Jin, Medyssey’s vice president of sales for the Americas, said.

According to growth consulting services firm Frost & Sullivan Inc., more than 30 million people suffer from back pain in the United States. The LP Cage was developed to help the 4.5 million people who still experience pain despite physical therapy and medication, and for whom spinal surgery is recommended. The device also addresses a market need for advanced spinal fusion solutions and maximum endplate-to-endplate contact; it is comprised of two footprints with three varying degrees of lordosis and substantial graft windows.

Medyssey also announced an 84 percent increase in U.S. sales in the first quarter of 2011 compared with the same period last year. .

“Medyssey’s focus is to have the most complete thoracolumbar systems on the market,” Jin said.

Medyssey Spine is privately owned and headquartered in Seoul, South Korea.