Devices Orthopaedic Neurosurgery FDA

 News Release - March 1, 2012

K2M Expands Complex Spine Product Offering with 510(k) Clearance for SANTORINI(TM) Corpectomy Cage Systems

LEESBURG, Va.--(Healthcare Sales & Marketing Network)--K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the SANTORINI™ Corpectomy Cage Systems. This new addition to the company’s growing complex spine portfolio is designed to replace collapsed, damaged, or unstable vertebral bodies due to trauma or tumor and provide anterior spinal column support.

SANTORINI cages, manufactured from biocompatible PEEK polymer, allow for an unobstructed view of the post-operative fusion and will be available as both solid and expandable options in a variety of sizes. SANTORINI Solid offers an enlarged graft space, while SANTORINI Expandable allows for in-situ expansion with a locking clip to secure the desired height.

According to Charles S. Theofilos, MD, Founder and Director of The Spine Center in Palm Beach Gardens, Florida, “The SANTORINI Expandable PEEK corpectomy cage offers precise intraoperative expansion with the stability of a solid peek implant. Its versatility and strength in spinal reconstruction is a welcome addition to the K2M product line.”

“FDA clearance for SANTORINI is an important expansion of our complex spine product offering, particularly in the areas of trauma and tumor spinal surgeries,” stated Eric Major, K2M’s President and CEO. “As the first addition to K2M’s portfolio in 2012, we’re proud to offer surgeons and patients new products that continue to highlight our commitment to treating the full spectrum of spine pathologies.”

About K2M

K2M, Inc. is an innovative spinal device company committed to the research, development, and commercialization of simplified solutions for the treatment of complex spinal pathologies and minimally invasive procedures. The company is recognized as a worldwide leader in providing unique technologies for the treatment of deformity, degenerative, trauma, and tumor spinal patients. K2M’s complete portfolio of next generation products includes: spinal stabilization systems, minimally invasive systems, and other advancing technologies such as motion preservation, annular repair, and nucleus replacement. Additional information is available online at www.K2M.com.

Source: K2M

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