K2M Gains Clearance for Cayman Minimally Invasive Plate System

Leesburg, Va.-based K2M Inc., a spine device company focused on complex spinal pathologies and minimally invasive procedures, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Cayman Minimally Invasive (Cayman MI). The device is the latest addition to K2M’s Cayman family of plate systems which are designed to provide a simplified solution to address fractures, tumors, and degenerative conditions in the anterior and lateral spinal column.

Cayman MI is a single-level, lateral plate designed to offer surgeons a 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.

The company recommends the use of Cayman MI in conjunction with its Ravine lateral access system, which provides a dual flat blade platform for a less invasive muscle-splitting transpsoas approach. This combination, the company hopes, will allow surgeons to preserve the position of the lateral implant and insert the plate without repositioning the Ravine retractor.

“The Cayman MI lateral plate offers surgeons a truly minimally invasive and streamlined technique to perform a lateral lumbar fusion,” said Clifford Douglas, M.D., a neurosurgeon working in Riverside, Calif. “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 MI 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,” said 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.”