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news.K2M, a spinal device company, has received 510(k) clearance from the FDA to market its Cayman buttress plate system and Cayman thoracolumbar plate system, which have been designed to address the trauma and tumor market in the thoracolumbar, lumbar, and sacral areas of the spine.
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The Cayman product family 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 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, the company said.
Eric Major, president and CEO of K2M, said: “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.”