ChoiceSpine recently announced that it has received clearance from the US Food and Drug Administration (FDA) to market the Blackhawk Ti 3D-printed cervical spacer system with standalone clearance.
Blackhawk Ti utilises pre-assembled integrated anchor technology with a proven cam-locking mechanism. Featuring a BioBond 3D-printed titanium porous structure, Blackhawk Ti is available in two anatomical footprints with significant room for graft material and large lateral windows for enhanced visual confirmation, as a ChoiceSpine press release states.
The expanded indication of the Blackhawk Ti standalone cervical spacer system to a pre-existing lineup of “world-class” ChoiceSpine solutions comes with “great industry enthusiasm”, the release adds, and the company is “eager” to release the system with expanded indications into the market.
“The Blackhawk Ti standalone cervical spacer system provides excellent intra- and post-operative results for my patients requiring the anterior cervical approach,” said Anders Cohen (The Brooklyn Hospital Center, Brooklyn, USA), lead design surgeon for the Blackhawk Ti system. “The wide variety of implant footprints and profiles allows for restoration of disc height and optimal sagittal balancing. Furthermore, what sets the Blackhawk Ti apart from others is the simplicity of the implant design with its integrated bone anchors and instrumentation that help reduce surgery time by decreasing the number of steps in the procedure.”
“The expanded indication of the Blackhawk Ti standalone cervical spacer system is the natural progression for the product platform,” added Steve Ainsworth, ChoiceSpine’s executive vice president of strategy and technology. “Blackhawk Ti is the first to market a 3D-printed system that utilises pre-assembled integrated anchor technology. Blackhawk Ti is just one of ChoiceSpine’s numerous 3D-printed titanium fusion solutions. This standalone clearance is an excellent example of how ChoiceSpine brings technically superior spinal devices to the market and does spine the right way.”