The Food & Drug Administration said ReGen Biologics Inc. (OTC:RGBO) failed to produce adequate evidence that its Menaflex knee implant was safe before it was cleared to hit the market in late 2008.
Documents released by the federal watchdog agency question whether the Hackensack, N.J.-based company supplied enough data on pre-clinical mechanical testing of the device, which is designed to repair damage to the meniscus cartilage in the knee. The documents also question ReGen’s claims that the device is similar enough to other devices for shoulder, bladder and hernia repair to merit the FDA’s fast-track 510(k) clearance process.