FDA Clears Nextremity Solutions’ Cannulated Hammertoe System

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., has received 510(k) clearance by the U.S. Food and 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 of 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 and 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.