FDA OKs Enovis’ Patient-Specific Instrumentation for STAR Ankle

Enovis has earned U.S. Food and Drug Administration (FDA) approval for its STAR patient-specific instrumentation (STAR PSI system) for use with the company’s STAR total ankle replacement system.
 
“Today is an exciting day for our customers and patients,” Gary Justak, president of Enovis Foot & Ankle told the press. “We acquired the STAR Ankle just two years ago, and the FDA approval of STAR PSI is just one example of our team’s commitment and investment to taking this best-in-class product to the level it deserves. Surgeons now have leading pre-operative planning and cutting guides, that when paired with years of proven, clinical data, set STAR Ankle up for a brilliant future.”
 
The STAR PSI system offers a personalized pre-op plan. Surgeons receive and review a 3D visualization of the patient’s ankle joint, including info about existing implants and/or bone defects, to plan for the ankle replacement case. An updated and simplified surgical technique can help reduce operative time during surgeries.
 
“I’m excited about the Enovis addition of PSI technology which will have great benefit to STAR patients by providing personalized cutting guides and accurate implant sizing to match their unique anatomy,” said Dr. Gregory Lundeeni, a foot and ankle orthopedic surgeon based in Reno, Nev. “Surgeons will be able to take advantage of the improved precision and efficiency of STAR’s patient specific cut guides.”
 
The product is entering Early Product Surveillance in December, with plans to fully launch by the end of March 2023.