K2M, Inc., the spinal device company developing innovative and simplified solutions for the treatment of complex spinal pathologies and procedures, today announced the introduction of a revolutionary minimally invasive approach to dynamic fixation of the spine. The POTOMAC™ Rod System and the SERENGETI™ Minimally Invasive Retractor System have received CE Mark clearance for international distribution to expand the global presence of K2M technologies.The POTOMAC Rod System, which will be distributed outside the United States, provides a simple and versatile one-piece rod design to enhance the stabilization characteristics of the spine. K2M has secured the exclusive rights to a unique manufacturing process of the material properties of “Nitinol,” a shape memory alloy. The intrinsic elasticity of the rod provides stabilization of the spine, while potentially reducing problems typically associated with traditional fusion materials. Additionally, the simplistic design allows POTOMAC to be implanted using traditional surgical techniques or by using the innovative SERENGETI Minimally Invasive Retractor System.SERENGETI, which was introduced into the market in 2007, offers a novel approach for the insertion of spinal implants through very small incisions. This percutaneous approach has been designed to provide improved visualization and access for multi-level complex posterior instrumentation procedures.
To date, K2M has received CE Mark clearance for several of its products including: RANGE™ Spinal System, MESA™ Spinal System, DENALI™ Spinal System, PYRENEES™ Cervical Plate System, and ALEUTIAN™ Spacer Systems. Similar to 510(k) clearance in the United States, the CE Mark allows for the sale and distribution of products for specific indications within Europe and other countries.
“The introduction of SERENGETI and POTOMAC marks another important milestone in K2M’s mission to continually provide surgeons with techniques and technologies that will enhance their ability to treat spinal patients,” stated Eric Major, K2M’s President and CEO. “CE Mark clearance for these next generation products expands the K2M product offering and fuels our rapid growth into the global markets, helping to position K2M as a leader for developing solutions to help surgeons address the most complex spinal pathologies.”