Le Lézard
Classified in: Health
Subject: FDA

ChoiceSpinetm Granted Expanded FDA Clearance for HAWKEYEtm Ti VBR Device


KNOXVILLE, Tenn., April 2, 2019 /PRNewswire-PRWeb/ -- ChoiceSpine LLC, a privately-held spinal device manufacturer based in Knoxville, TN, was granted 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, for use in the cervical spine. This new indication expands the already cleared T1 to L5 indication for HAWKEYE Ti to cover C1 to L5.

"The HAWKEYE Ti expanded indication provides our surgeon customers and their patients access to a revolutionary device well-suited for use in cervical spinal fusion procedures," said Rick Henson and Marty Altshuler, co-presidents of ChoiceSpine. "The complete HAWKEYE Ti portfolio, cleared to be marketed in all three spinal segments, allows us to meet the clinical demands of surgeons and the anatomical needs of patients to be their choice partner in spinal fusion surgery."

HAWKEYE Ti Vertebral Body Replacement System was designed to stabilize and fuse the vertebral column with a competitive implant portfolio consisting of both, a small and medium size footprint that ranges in heights from 14 to 60 mm with a built-in 0° or 8° of lordosis. HAWKEYE Ti has a large center chamber that provides for bone grafting from the inferior vertebral endplate straight through to the superior endplate. In addition, the lateral windows allow surgeons to assess spinal fusion over time.

"HAWKEYE Ti marries a proven VBR device design with 3D-printed, titanium technology to provide a clinical solution to cervical, thoracic and lumbar spinal fusion procedures," said KC Gilbert, Vice President of Marketing & Professional Education, ChoiceSpine. KC continued, "ChoiceSpine will continue to expand the commercial release of HAWKEYE Ti through the second quarter of 2019." For more information, please visit our website at: choicespine.com.

About ChoiceSpine
ChoiceSpine is a spinal device company located in Knoxville, TN and is privately-held by Altus Capital Partners. The Company prides itself on providing innovative, solutions-based products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of 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 network, ChoiceSpine will continue to bring technically-superior spinal products to market.

About Altus Capital Partners
Altus Capital Partners is a private equity firm that makes control investments in middle market manufacturing businesses. We believe that our exclusive focus on manufacturing provides us with a unique understanding of the opportunities and challenges faced by companies in the sector. We utilize a patient, thoughtful investment approach and seek to partner with the management teams of our operating companies to achieve growth. With offices in Wilton, CT and Lincolnshire, IL, Altus Capital Partners has completed 18 platform investments and numerous add on acquisitions since 2003. For more information, please visit http://www.altuscapitalpartners.com.

 

SOURCE ChoiceSpine


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News published on 2 april 2019 at 05:45 and distributed by: