Enovis receives FDA approval for patient-specific total ankle replacement instrumentation

Fact checked byGina Brockenbrough, MA

Enovis Corporation has announced FDA approval of the Scandinavian Total Ankle Replacement Patient Specific Instrumentation for use with the company’s total ankle replacement system, according to a company press release.

The Scandinavian Total Ankle Replacement Patient Specific Instrumentation (STAR PSI), designed for use with the STAR (Enovis) total ankle system, offers surgeons a preoperative plan with 3D visualization and anatomic information on implants or bone defects in each patient, according to the release.

Sign outside FDA HQ in Washington, DC. — Enovis received FDA approval of the Scandinavian Total Ankle Replacement Patient Specific Instrumentation for use with the company’s total ankle replacement system. Source: Adobe Stock

“Today is an exciting day for our customers and patients,” Gary Justak, president of Enovis foot and ankle, said in the release. “We acquired the STAR ankle just 2 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 preoperative planning and cutting guides, that when paired with years of proven, clinical data, set STAR ankle up for a brilliant future,” Justak said.

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Enovis receives FDA approval for patient-specific total ankle replacement instrumentation

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