K2M’s SANTORINI™ Corpectomy Cage Systems Gain FDA Clearance March 6, 2012
“The SANTORINI Expandable PEEK corpectomy cage offers precise intraoperative expansion with the stability of a solid peek implant.”
Spinal company K2M, Inc., has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its 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.
K2M, Inc. describes itself as being committed to the research, development, and commercialization of simplified solutions for the treatment of complex spinal pathologies and minimally invasive procedures. Specifically it provides unique technologies for the treatment of deformity, degenerative, trauma, and tumor spinal patients.
K2M’s 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.
Outside USA K2M has offices in UK and Germany and a network of distributors. The company expects to announce CE marking of SANTORINI by the end of March 2012.
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.”
Source: K2M Inc