ChoiceSpine™ Granted FDA Clearance for 3D Printed Vertebral Body Replacement Device
KNOXVILLE, TN (PRWEB) OCTOBER 04, 2017
ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market HAWKEYE Ti, a 3D Printed Titanium Vertebral Body Replacement (VBR) device.
“Additive manufacturing techniques create intricate three-dimensional implants, layer by layer, allowing a freedom in design and surface unattainable through conventional machining,” explained Stephen Ainsworth, PhD, Vice President of Research & Development, ChoiceSpine. “It revolutionizes our approach to design and the benefits we can now offer to our spine surgeon customers and their patients.”
HAWKEYE Ti offers the same complete implant portfolio as the original PEEK HAWKEYE device with the added advantage of a 3D printed, open titanium structure optimized for bone in-growth. HAWKEYE Ti is the first of many 3D printed devices being developed and commercialized by ChoiceSpine.
The HAWKEYE Vertebral Body Replacement System was designed to stabilize and fuse the vertebral column with elegantly simple implants in a variety of shapes and sizes. The portfolio contains small and large footprints that range in size from 10 to 50 mm in height with either 0° or 6° lordosis. “The breadth of this portfolio married with the new 3D printed implants provides a wide variety of options to match varying patient anatomies and surgical needs,” said KC Gilbert, Vice President of Marketing & Professional Education, ChoiceSpine.
“The clearance of our first additively manufactured device is a great achievement for the ChoiceSpine R&D team and the company,” said Rick Henson and Marty Altshuler, co-founders of ChoiceSpine. “HAWKEYE Ti allows us to meet the clinical demands of spine surgery in order to stay competitive in a dynamic market.”
About ChoiceSpine
ChoiceSpine is a privately-held spinal device company located in Knoxville, TN. The Company prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon-focused systems that are designed to be safe, efficient and easy-to-use. By working closely with physicians and maintaining a service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to market.
