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Total Ankle Replacement System Approved by the FDA – The Star System

Posted Jun 01 2009 10:43pm

Finally an ankle replacement approved by the FDA.  Another company, Endotec went to court with the FDA not too long ago and I didn’t know if we were every going to see ankles out there, but Small Bones Innovations has the approval.  image

“It's not often the little guy takes on the federal government and wins. Endotec, a small South Orange maker of orthopedic devices, did just that this summer after years of fighting with the Food and Drug Administration for permission to legally market its unique ankle joint replacement implant.”

They also have more products, even one for your thumb in case you over do it on your cell phone or Blackberry.  BD 


From the Website: 

The SBi S.T.A.R. ® is the treatment option for moderate to serious ankle arthritis, for relieving pain and mimics normal anatomical movement in restoring motion. It is a safe, proven alternative to failing conservative treatment. The S.T.A.R. ® has published superior outcomes and is statistically superior to ankle fusion.
The S.T.A.R. ® Ankle has a 30 year development history beginning with the development of the first generation S.T.A.R.® prosthesis by Hakon Kofoed, MD*, in 1978. The S.T.A.R. Ankle has been used clinically since 1990 with over 14,500 implantations performed worldwide.

FDA recently approved a total ankle replacement system, the Scandinavian Total Ankle Replacement (STAR) system.

STAR may preserve some range of motion in arthritic or deformed ankles, according to the Atlanta Journal-Constitution.

This is the first type of system approved for ankle deformities or like injuries of the ankle. STAR uses bearings that move across a surface of flexible plastic (polyethylene).


When someone is experiencing or has arthritic or a deformed ankle, they may undergo a surgery called Fusion surgery. Fusion surgery is where the shin bone is cemented to the talus bone in the ankle. This surgery is suppose to stabilize the ankle but adversely decreases a patient’s ability to move their foot up and down.

STAR System Approved by FDA | InjuryBoard Atlanta

Related Reading:

A New era of artificial ankles

FDA Shackled at the Ankles?

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