K2M Receives 510(k) Clearance for its tifix CAYMAN Plate Systems
LEESBURG, VA … February 10, 2009 – K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its CAYMAN™ Buttress Plate System and CAYMAN™ Thoracolumbar Plate System, which have been designed to address the trauma and tumor market in the thoracolumbar, lumbar, and sacral areas of the spine.
The CAYMAN product family is comprised of multiple implant systems, including a buttress plate to address graft expulsion, a lower lumbar sacral plate, and additional plating designs to secure and stabilize the anterior column. The low-profile plate features K2M’s proprietary tifix® Locking Technology, a plate-screw locking technology whereby each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism. Additionally, the multi-directional screws allow for up to 45 degrees of angulation and lagging of the plate implant to the bone interface.
“FDA clearance for our CAYMAN Plate Systems is an important expansion of our product offering to surgeons for treating trauma and tumor spinal patients. This comprehensive product family provides surgeons with a very low profile option for treating the spine from an anterior and lateral approach,” stated Eric Major, K2M’s President and CEO. “CAYMAN is also a critical compliment to our ALEUTIAN™ PEEK-OPTIMA® spacer product lines by offering surgeons the opportunity to utilize both systems at the same time when treating the most difficult pathologies.”
K2M, Inc. is an innovative spinal device company that develops simplified solutions for the treatment of complex spinal pathologies and procedures. Chief Medical Officer, Chairman and co-founder, Dr. John Kostuik, former Chief of Spine Surgery at The Johns Hopkins University School of Medicine, drives K2M’s commitment to redefining the market. K2M’s comprehensive line of products include: spinal stabilization systems, minimally invasive systems, and other advancements in spine solutions for degenerative disc disease (DDD), as well as deformity, trauma, and tumor. Additional information is available online at www.K2M.com.
Marketing Communications Manager