Uncategorized

FDA panel backs approval for J&J hip replacement

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.

Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

Related Articles

Leave a Reply

Your email address will not be published. Required fields are marked *

Back to top button