FDA Issues Warning Letter for Off-Label Promotion of Orthopedic Implant

Orthopedic implants company Amedica Corp. promoted off-label use of its compact vertebral body replacement device without seeking marketing clearance by the U.S. Food and Drug Administration (FDA), according to a Jan. 27 warning letter from the agency.

The FDA considers the Valeo-C VBR misbranded because the company promoted uses that were not approved in its 510(k) application and made changes that could affect the safety and effectiveness of the device, the letter stated. The FDA investigated the company Aug. 7-20.

Amedica, which is based in Salt Lake City, Utah, received a CE mark for its Valeo family of ceramic spinal intervertebral spacers in 2008. The Valeo family of ceramic spinal intervertebral spacers is intended to aid in surgical correction and stabilization of the thoracolumbar spine.

See the entire warning letter at www.fda.gov/foi/warning_letters/s7113c.htm.