Memphis,Tenn.-based Active Implants’ TriboFit Hip System has received the European Union’s CE Mark Class III approval for medical devices with high risk, according to a release from Active Implants.
Active Implants said the device had already received the EU’s CE Mark Class IIb approval and was selling in select European markets, but the company is still applying for U.S. FDA approval while TriboFit goes through U.S. trials.
TriboFit, a polycarbonate-urethane acetabular implant, includes a gelatinous-like hydrophilic substance that imitates the fluid film layer naturally present in joints.
Read Active Implants’ release on European approval of TriboFit.
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