WASHINGTON (AP) — A panel of federal health experts on Tuesday unanimously recommended approval for an experimental hip replacement system from health care products maker Johnson & Johnson.
The Food and Drug Administration’s outside panel of orthopedic experts voted 5-0 that the Pinnacle Complete implant system appears safe and effective, according to an agency spokeswoman.
Panelists recommended approval, provided the New Brunswick, N.J.-based company conduct a 10-year follow-up safety study.
The FDA is not required to follow the panel’s advice, though it usually does.
J&J’s Depuy unit has asked the FDA to approve its device for patients who need a total replacement of the ball-and-socket hip joint due to damage or deterioration. A diseased hip joint can cause pain and disability.
About 193,000 total hip replacements are performed in the U.S. each year, according to the American Academy of Orthopedic surgeons.