ChoiceSpine™ Announces FDA Clearance and Clinical Use of Blackhawk™ Ti Cervical Spacer System

Wednesday, May 26, 2021

ChoiceSpine LLC, a privately held spinal device manufacturer based in Knoxville, TN, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the Blackhawk Ti Cervical Spacer System.

Anders Cohen, DO, the Lead Design Surgeon for the Blackhawk Ti system, stated, “Blackhawk Ti improves and builds upon the already successful original Blackhawk PEEK device with integrated anchor technology. The addition of 3D-printed porous titanium technology, and the implant’s unique updated design both play a role in the bone growth process during fusion. However, what really sets this system apart from others is the simplicity of the implant design and instrumentation that help to significantly reduce surgery time by decreasing the number of steps in the procedure.”

“We are excited to announce the launch of our newest 3D-printed cervical spacer system,” said Steve Ainsworth, PhD, ChoiceSpine’s Executive Vice President of Strategy and Technology. Blackhawk Ti is the first to market 3D-printed system that utilizes preassembled integrated anchor technology. Blackhawk Ti is a significant addition to ChoiceSpine’s 3D-printed titanium fusion solutions portfolio. This innovation is just one example of how ChoiceSpine is bringing technically superior spinal devices to the market and doing spine the right way.

The Blackhawk Ti Cervical Spacer System includes:

  • BioBond™ 3D-printed titanium porous matrix
  • Large open graft window for bone graft containment & maximum visualization
  • 6° Lordotic and Convex configurations available
  • Simultaneous, single-step anchor deployment
  • External locking indication for easy confirmation of cam-locking mechanism
  • Preassembled integrated anchor technology
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