K2M receives FDA clearance to market CAYMAN Minimally Invasive plate system

Jan 9 2014

K2M, Inc., the largest privately held spinal device company in the world focused on developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market CAYMAN^® Minimally Invasive, the latest addition to the company’s CAYMAN product family of plate systems already featuring CAYMAN Anterior, CAYMAN Buttress and CAYMAN Lateral.

The CAYMAN Plate Systems provide a simplified solution to address fractures, tumors, and degenerative conditions in the anterior and lateral spinal column. CAYMAN Minimally Invasive is a single-level, lateral plate designed to offer surgeons a truly minimally invasive surgical option. The low-profile, four screw construct 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 biased plate screw holes allow for screw angulation of 15 degrees normal to the plate.

Used in conjunction with K2M’s RAVINE^® Lateral Access System, which provides a dual flat blade platform for a less invasive muscle-splitting transpsoas approach, CAYMAN Minimally Invasive allows surgeons to preserve the position of the lateral implant and insert the plate without repositioning the RAVINE retractor. The RAVINE system represents an innovative design departure from the tubular retractors, while providing tremendous adaptability to both patient anatomy and surgeon technique.

According to Clifford Douglas, MD, “The CAYMAN MI lateral plate offers surgeons a truly Minimally Invasive and streamlined technique to perform a Lateral Lumbar fusion. When used in conjunction with K2M’s RAVINE Lateral Access System and the ALEUTIAN Lateral Interbody, I am able to secure the construct with the CAYMAN MI plate all with one single incision. Not having to worry about tissue creep and retractor position during the insertion of the plate makes this system easy to use.”

“FDA clearance for CAYMAN Minimally Invasive marks another significant expansion of our growing product portfolio, and provides surgeons with a unique minimally invasive treatment option for patients who will be best served by a lateral approach,” stated Eric Major, K2M’s President and CEO. “The expansion of our CAYMAN Plate Systems not only enhances K2M’s lateral offering, but reaffirms our commitment to being a leader in the minimally invasive market worldwide.”