ChoiceSpine™ Granted FDA Clearance for Two New Cervical Spinal Fusion Devices
KNOXVILLE, TENN. (PRWEB) MAY 14, 2019
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 TIGER SHARK C interbody device with BioBond™ technology and BOOMERANG Anterior Cervical Plate (ACP) with a two-screw configuration, for use together or separately in cervical spinal fusion procedures.
“BOOMERANG is a versatile system of implants and instrumentation designed to simplify and improve the efficiency of anterior cervical spinal fusion procedures,“ remarked KC Gilbert, Vice President, Marketing & Education, ChoiceSpine. “The instrumentation also allows spine surgeons to simultaneously insert the BOOMERANG plate with our cervical interbody devices, such as TIGER SHARK C or STEALTH™, mimicking a stand-alone ACDF concept, eliminating surgical steps and reducing time in the operating room.”
BOOMERANG ACP features a streamlined, two-screw configuration and a single-step screw blocking mechanism for fast insertion and fixation to the anterior cervical spine. The low-profile, offset design allows for stackability at adjacent levels and enhances visual confirmation of the cervical graft in the disc space. The System’s streamlined instrumentation facilitates a simplified surgical approach while providing excellent control during the procedure.
TIGER SHARK C is a 3D manufactured, titanium alloy, cervical interbody device created with the trademarked BioBond technology. BioBond is an organic, porous interbody architecture designed for continuous porosity with an osteoconductive, hydrophilic surface. TIGER SHARK C is available in an assortment of heights with 6° of lordosis to accommodate different cervical anatomical requirements.
“We are extremely proud of our team at ChoiceSpine for successfully achieving these two FDA clearances,” said Marty Altshuler and Rick Henson, co-presidents of ChoiceSpine. “TIGER SHARK C and BOOMERANG ACP represent the ChoiceSpine commitment to providing our surgeon customers with innovative, surgeon-focused systems designed to deliver the best clinical outcomes for their spinal surgery patients.”
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.
