Friday, October 3, 2008

FDA approves Orthofix spinal fixation device

By Mass High Tech Staff

Orthopedic medical device firm Orthofix International NV was granted 510(k) approval from the U.S. Food and Drug Administration for its Firebird spinal fixation system.

Used with minimally invasive surgery or during spinal disc disease treatments and thoracolumbar spine procedures, the Firebird system is made to add intra-operative flexibility using a modular screw.

Orthofix (Nasdaq: OFIX)  has received three FDA approvals, including this most recent one, for spinal products in the last two months. Company officials reported plans to grow its spine division through product launches.

Last month, the company made some management changes by appointing Robert Vaters to the position of executive vice president and chief financial officer. He replaces long-time CFO Tom Hein, who will now become the company’s executive vice president of finance. It also brought in Brad Mason to serve as president of Orthofix subsidiary Blackstone Medical Inc. in Springfield.

Orthofix International offers surgical, as well as nonsurgical, products for the spine, reconstruction and trauma market sectors that address lifelong bone-and-joint health needs of patients of all ages. The company has drawn $10.9 million in net profit in 2007 on $490 million in revenue. It reported a staff of 1,400 as of March 2008.