US-based spinal device company K2M has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Cayman minimally invasive (MI) system, a single-level, lateral plate designed to offer surgeons a truly minimally invasive surgical option.
Cayman MI system is the latest addition to the company’s Cayman product family of plate systems that include Cayman Anterior, Cayman Buttress and Cayman Lateral.
The Cayman MI plate system is intended for insertion through the Ravine lateral access system’s true muscle-splitting Retractor. It has a low profile, four screw design and the screws lock to the plate upon insertion by using the K2M’s tifix Locking Technology.
The device features biased plate screw holes which allow for screw angulation of 15 degrees normal to the plate.
When used in conjunction with K2M’s Ravine lateral access system, the Cayman MI system allows surgeons to preserve the position of the lateral implant and insert the plate without repositioning the Ravine retractor.
Ravine lateral access system provides a dual flat blade platform for a less invasive muscle-splitting transpsoas approach.
K2M president and CEO Eric Major noted the FDA clearance for Cayman MI marks another significant expansion of the company’s growing product portfolio, and provides surgeons with a unique minimally invasive treatment option for patients who will be best served by a lateral approach.
"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," Major added.