Wright Medical Snags FDA Clearance for Salvation External Fixation Device

Wright Medical said Wednesday that it received FDA 510(k) clearance to begin marketing its Salvation external fixation device for foot and ankle surgeries.

The system — designed to fix fractures, nonconnected bones and foot and ankle deformities — is comprised of a metal exoskeleton consisting of tensioned thin wires, half pins and metal rings that aligns the lower leg and foot during surgery, the devicemaker said.

The Salvation product line has been indicated to treat neuropathic osteoarthropathy, also known as Charcot foot, a foot-collapse disorder resulting from nerve damage.

CEO Robert Palmisano said the Memphis, Tenn., devicemaker will start gathering clinical and marketing data in preparation for a product launch, with limited physician testing set to occur during the second quarter.

Wright is in the midst of a $3.3 billion merger with Tornier, pending approval by U.S. antitrust regulators. — Jason Scott