In the News

It’s been a busy year so far at K2M, Inc.

The company announced on February 10 that it had received 510(k) clearance in the U.S. from the Food and Drug Administration to market its Cayman Buttress and Cayman Thoracolumbar Plate Systems.

The plates are designed to address the trauma and tumor market in the thoracolumbar, lumbar, and sacral areas of the spine.

The system is comprised of multiple implant systems, including a buttress plate to address graft expulsion, a lower lumbar sacral plate, and additional plating designs to secure and stabilize the anterior column. The low-profile plate 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 multi-directional screws allow for up to 45 degrees of angulation and lagging of the plate implant to the bone interface.

Eric Major, K2M's President and CEO commented in a press release: "FDA clearance for our Cayman Plate Systems is an important expansion of our product offering to surgeons for treating trauma and tumor spinal patients. This comprehensive product family provides surgeons with a very low profile option for treating the spine from an anterior and lateral approach. Cayman is also a critical compliment to our Aleutian PEEK-Optima spacer product lines by offering surgeons the opportunity to utilize both systems at the same time when treating the most difficult pathologies.”

On January 27, the company had also announced the introduction of a minimally invasive dynamic fixation system, the Potomac rod and the Serengeti minimally invasive retractor system. Those devices have received CE Mark clearance for international distribution.

The Potomac rod system is a one-piece rod design to enhance the stabilization characteristics of the spine. The Serengeti, which was introduced into the market in 2007, offers, according to the company, a percutaneous approach for the insertion of spinal implants through very small incisions.

Cayman…Potomac…Serengeti…sounds like a great trip!