K2M granted FDA clearance for CHESAPEAKE Anterior-Lumbar Stabilization System

K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new CHESAPEAKE^™ Anterior-Lumbar Stabilization System, a unique interbody device designed for stabilization of the spine through an anterior approach. The system provides screw fixation through K2M's revolutionary tifix^® Locking Technology, whereby each screw head forms an autogenic lock to the implant upon insertion.

“CHESAPEAKE is the perfect offering for low-profile interbody instrumentation and, in my opinion, is the future of vertebral arthrodesis”

CHESAPEAKE, an implant manufactured from biocompatible PEEK polymer, allows for anterior stabilization and fixation with a zero-profile design. Additionally, the system utilizes innovative instrumentation, such as the Anterior Insertion Ramp, which allows for parallel distraction and controlled threaded insertion while applying a zero-impact load on the interbody.

"CHESAPEAKE is the perfect offering for low-profile interbody instrumentation and, in my opinion, is the future of vertebral arthrodesis," stated Dr. Amiel Bethel, Division Head, Department of Surgery at Greater Baltimore Medical Center.

According to Dr. John I. Williams, Orthopedic Surgeon at Ortho NorthEast, "The screws utilize a unique tifix Locking Technology, which not only adds simplicity to the system, but gives an element of variability in terms of screw angulation into the vertebral body."

"FDA clearance for our CHESAPEAKE Anterior-Lumbar Stabilization System is an important expansion of our product offering for treating Degenerative Disc Disease (DDD), as well as more complex pathologies," stated Eric Major, K2M's President and CEO. "The zero-profile design and innovative locking technology facilitate and streamline anterior spinal stabilization and fixation procedures."

Source K2M, Inc.