CLEVELAND, Nov. 30, 2011 /PRNewswire/ --RSB Spine announced today that it received a revised FDA clearance letter for the InterPlate® System as both an interbody implant with integrated fixation and an anterior screw fixation device. FDA recently instituted new product codes for stand-alone interbody devices with integrated fixation. The new code for lumbar interbody devices is OVD, and the new code for cervical interbody devices is OVE. In addition to these new product codes, the InterPlate retained code KWQ for anterior screw fixation in the spine.
Stand-alone interbody fusion devices were introduced in the U.S. in 2004. They generally consist of an interbody spacer with screw fixation or other mechanisms that engage adjacent vertebrae. The North American Spine Society (NASS) issued a statement in SpineLine (Coding for Anterior Lumbar Arthrodesis & Instrumentation, November/December, 2007) stating that such devices should be coded as "22558: Arthrodesis, anterior interbody technique..." and "22851: Application of intervertebral biomechanical device…". The guideline further stated that "An additional anterior instrumentation code (22845) is not applicable because there is not a separate construct placed across the vertebral segment." The American Academy of Professional Coders (AAPC) also adopted the NASS position.
"There has been a great deal of confusion and controversy with stand-alone interbody devices," said Dahari D. Brooks, M.D. of Greensboro Orthopaedics in Greensboro, North Carolina. "The new FDA codes make it easier for surgeons to properly bill and insurers to properly reimburse for these interbody technologies."
"The InterPlate product line is a modular interbody platform and in that regard is different than other stand-alone implants," said John Redmond, CEO of RSB. "The new FDA codes and the retention of our KWQ code help to clarify this difference and provide surgeons with the advantages of a stand-alone implant and the ability to code as a typical anterior plate construct."
RSB Spine is a privately held medical device company focused on developing innovative spinal implants with a focus on modular fusion products. News releases and other information on the company are available on the Internet at: http://www.rsbspine.com.
SOURCE RSB Spine