Santorini corpectomy cage systems get FDA 510(k) clearance


The US Food and Drug Administration (FDA) has given 510(k) clearance to K2M to market the Santorinicorpectomy cage systems which are designed to replace collapsed, damaged, or unstable vertebral bodies due to trauma or tumor and provide anterior spinal column support.  

The 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.

“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,” said Charles S Theofilos, founder and director of The Spine Center in Palm Beach Gardens, Florida, USA.