K2M obtains FDA 510(k) approval for Cayman minimally invasive system

8 January 2014 (Last Updated January 8th, 2014 18:30)

Spinal device manufacturer K2M has received 510(k) approval from the US Food and Drug Administration (FDA) for its Cayman minimally invasive (MI) system.

Spine

Spinal device manufacturer K2M has received 510(k) approval from the US Food and Drug Administration (FDA) for its Cayman minimally invasive (MI) system.

The Cayman MI system provides simplified solution to address fractures, tumours, and degenerative conditions in the anterior and lateral spinal column.

The single-level, lateral plate system is specifically designed for insertion through the Ravine lateral access system's true muscle-splitting Retractor. The system's stackable design allows for one-level and multi-level constructs.

It provides a dual flat blade platform for a less invasive muscle-splitting transpsoas approach.

According to the company, the Ravine system represents a new design departure from the tubular retractors and provides tremendous adaptability to both patient anatomy and surgeon technique.

When used in conjunction with 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. Its plate has a low-profile design and the screws lock to the plate upon insertion by using K2M's proprietary tifix Locking Technology.

"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."

tifix Locking Technology is a plate-screw process, where each screw head forms an autogenic lock to the plate upon insertion and does not require additional locking mechanism.

The biased plate screw holes of the system allow for screw angulation of 15° normal to the plate.

K2M president and CEO Eric Major said that FDA clearance for Cayman minimally invasive marks another significant expansion of the company's growing product portfolio.

"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 said.

The minimally invasive system is the latest addition to the K2M's Cayman product family of plate systems, which includes Cayman Anterior, Cayman Buttress and Cayman Lateral.


Image: Cayman MI provides surgeons with a unique minimally invasive treatment option for patients. Photo: courtesy of freedigitalphotos.net.