K2M Receives 510(k) clearance for Chesapeake Anterior-Lumbar Stabilisation System


K2M has announced that it has received 510(k) clearance from the US FDA to market its new Chesapeake Anterior-Lumbar Stabilisation System, a unique interbody device designed for stabilisation 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, an implant manufactured from biocompatible PEEK polymer, allows for anterior stabilisation and fixation with a zero-profile design. Additionally, the system utilises 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,” said Amiel Bethel, division head, department of surgery at Greater Baltimore Medical Center, US.

According to John I Williams, orthopedic surgeon at Ortho NorthEast, “The screws utilise a unique locking echnology, 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, 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 stabilisation and fixation procedures.”