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SBi rHead Extended Stem wins FDA clearance

Small Bone Innovations, Inc (SBi), an orthopedics company, has received the US Food and Drug Administration (FDA) 510(k) pre-market clearance notification for its radial Head (rHead) Extended Stem to be used in the correction of complex elbow instabilities and/or elbow reconstruction.

The rHead Extended Stem is intended to be used in conjunction with SBi‘s Elbow Management System (EMS) and incorporates an algorithmic approach to provide surgeons an array of solutions for treating elbow fractures.

Addition of the rHead Extended Stem to EMS increases treatment options for elbow fractures where fixation may be inadequate and further expands SBi’s upper limb product line .

SBi chairman and CEO Anthony Viscogliosi said the rHead Extended Stem was designed to be easily integrated with the EMS and provides surgeons greater flexibility to treat complex elbow fractures.

"The addition of the extended stem to their product portfolio is another step towards creating the most attractive, anatomically-focused product portfolio dedicated to restoring form, function and motion while alleviating pain in upper limb joints," Viscogliosi said.