Stryker OP-1

Orthopedic recombinant human protein European launch is slated for the third quarter following CE mark approval May 17. The device is indicated for treatment of non-union fractures of the tibia of at least nine months duration in skeletally mature patients in cases where previous autograft has failed or use of autograft is not feasible. In the U.S., the firm continues its discussions with FDA after the agency issued a not-approvable letter for the product in January due to insufficient radiographic data (1"The Gray Sheet" Feb. 5, 2001, p. 7)