Healthcare Industry News: Fixation System
News Release - October 14, 2008
US Spine Announces FDA 510(k) Clearance for Preference 2 Complex Spine System(TM)
BOCA RATON, Fla.--(HSMN NewsFeed)--US Spine® today announced that the FDA has cleared its Preference 2 Complex Spine System™ for use in the United States. The system features hooks, rods and screws designed to treat complex spinal conditions.Advanced correction instrumentation, Cobalt Chrome Rods, Lateral Offset Connectors, Hooks, Rod-to-Rod Connectors and a Low-profile Cross Connector are among the many new components that make up the system. All anchoring implants within the system feature the Helical Flange® Closure mechanism, which eliminates head splay and drastically reduces cross threading.
Leading spine surgeons with backgrounds in both pediatric and adult deformity developed the system, with the goal of providing a low-profile, flexible and powerful offering that gives surgeons a no-compromise solution to treat complex spinal disorders. The system will be on display this week at the North American Spine Society’s (NASS’) annual meeting in Toronto. Other US Spine technologies exhibited at NASS this year include the company’s Facet Gun and a preview of its Percutaneous Facet Fixation System.
FDA clearance for US Spine’s Preference 2 Complex Spine System allows the company to enter the Deformity, Tumor and Trauma market, estimated at over $700 million, and is the first of several new products from US Spine.
About US Spine: US Spine is a privately held, middle-stage medical device company focused on the development and commercialization of advanced spinal implant systems with breakthrough technology to address the rapidly increasing spine implant market. US Spine’s development efforts focus on motion and tissue preservation through the use of advanced biomaterials and expert surgeon designers. More information about the Company can be found at http://www.us-spine.com.
Source: US Spine Inc
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