ExtremitiesRegulatory

Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Cannulated Hammertoe System

WARSAW, IND. (PRWEB) JULY 03, 2020

Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the extremity musculoskeletal space, located in “The Orthopedic Capital of the World,” Warsaw, Ind., today announced it has received 510(k) clearance by the Food & Drug Administration to market its upcoming DuoHex™ CH System.

“Designed with an optimized array of implant threads for a variety of patient anatomy, a fully-guided cannulated system, and in-situ adjustment, the DuoHex CH system provides an exciting new technology for both patients and surgeons,” said Thomas Holton, Senior Engineer, Product Development for Nextremity Solutions.

The DuoHex CH System addresses hammertoe deformity in patients and provides surgeons with a novel two-piece threaded implant construct is designed for optimum bone purchase. The design of the cannulated implants and instruments provide targeting and technique guidance for repeatable outcomes. The implant-to-implant rotational stability is made possible thanks to the implant’s innovative hexagonal locking mechanism.

Ryan Schlotterback, Chief Technology Officer for Nextremity Solutions said, “Nextremity Solutions was founded years ago by surgeons with a passion for the foot and ankle market and with an innovative solution for hammertoe correction. After all this time, it was fun to revisit this common foot procedure and have the engineers go back to the drawing board. The team has done a fantastic job of taking our rich heritage and combining all we’ve learned over the years to commercialize another great solution for hammertoe correction. We’re excited about adding the DuoHex CH System to our rapidly expanding portfolio.”

“Once again, I am so proud of our team as we received our twelfth 510k approval to support yet another global solution to unmet needs of foot and ankle surgeons and their patients. We remain committed to our mission of becoming the premier Strategic Commercialization Company in the Extremity, Trauma, Sports Medicine and Joint Preservation market,” President & CEO, Rod K. Mayer added.

The Nextremity Solutions DuoHex CH Cannulated Hammertoe System is indicated for small bone reconstruction limited to interphalangeal repair and fusion of the lesser toes.

About Nextremity Solutions, Inc.
Nextremity Solutions, Inc. is a privately held strategic commercialization organization in the musculoskeletal space, offering innovative solutions and Revenue Ready products for various musculoskeletal applications and for the benefit of its industry partners. The Company’s procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

For further information, visit http://www.nextremitysolutions.com or call Dave Temple, Director of Marketing & Corporate Communications at 574-635-3022.

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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