The Food & Drug Administration’s regulatory clampdown on pedicle screw-based dynamic stabilization systems is inhibiting the development of a market for the spinal devices, according to a report from the Millennium Research Group.
The report, "U.S. Markets for Spinal Implant 2010" suggeststhat opportunities in the $265.6 million U.S. market for non-fusion technology have diminished. Millennium considered 522 post-market surveillance study letters that the FDA sent to manufacturers. Each letter requested additional clinical data to support the use of pedicle screw systems as an adjunct to fusion.
According to the report, the FDA requested information that was not required as a part of the devices’ original 510(k) application.
The spinal implant business, dominated by five giants that command nearly 80 percent of the global market, is seeing increased competition from smaller companies driving the development of innovative new products, according to a late-2009 report from Millennium.