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K2M Chesapeake wins FDA clearance

K2M, a spinal device company, has received the US Food and Drug Administration (FDA) 510(k) clearance to market its new Chesapeake anterior-lumbar stabilization system, an interbody device designed for stabilization of the spine through an anterior approach.

The system provides screw fixation through K2M’s tifix locking technology, whereby each screw head forms an autogenic lock to the implant upon insertion.

Chesapeake, an implant manufactured from biocompatible PEEK polymer, allows for anterior stabilization and fixation with a zero-profile design and utilises 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.

Greater Baltimore Medical Center Department of Surgery division head Amiel Bethel said that Chesapeake is the perfect offering for low-profile interbody instrumentation and, in my opinion, is the future of vertebral arthrodesis.

K2M president and CEO Eric Major said that FDA clearance for Chesapeake Anterior-Lumbar Stabilization System is an important expansion of product offering for treating Degenerative Disc Disease (DDD), as well as more complex pathologies and the zero-profile design and innovative locking technology facilitate and streamline anterior spinal stabilization and fixation procedures.