ChoiceSpine’s additively manufactured Blackhawk Ti cervical spacer system receives FDA clearance
September 22, 2023
ChoiceSpine LLC, a medical device company based in Knoxville, Tennessee, USA, owned by Altus Capital Partners, has announced that it has received clearance from the US Food and Drug Administration (FDA) to market the Blackhawk Ti additively manufactured cervical spacer system as a standalone device.
The Blackhawk Ti features preassembled integrated anchor technology with a cam-locking mechanism. It includes a BioBond additively manufactured titanium porous structure and is available in two anatomical footprints. The design allows space for graft material and includes large lateral windows for enhanced visual confirmation.
“The Blackhawk Ti Standalone Cervical Spacer System provides excellent intra and post-operative results for my patients requiring the anterior cervical approach,” stated Dr Anders Cohen, DO, Lead Design Surgeon. “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.”
Steve Ainsworth, PhD, ChoiceSpine’s Executive Vice President of Strategy and Technology, added, “The expanded indication of the Blackhawk Ti Standalone Cervical Spacer System is the natural progression for the product platform. Blackhawk Ti is the first to market a 3D printed system that utilises preassembled 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℠.”
ChoiceSpine offers a range of product lines specifically designed for surgeons, which are said to prioritise safety, efficiency, and ease of use. By fostering collaboration with physicians and industry partners, Choice Spine aims to deliver on product commitments, conduct innovative research and development, and offer up-to-date technology to the spinal market.
