Nextremity Solutions, Inc. Receives FDA 510(k) Approval for the Axi+LineTM Proximal Bunion Correction System
Warsaw, Indiana, December 22, 2015 — Nextremity Solutions, Inc., a surgeon-driven, pure-play foot and ankle orthopedic company located in Warsaw, Indiana, announced it has received 510(k) approval by the Food & Drug Administration to market its upcoming Axi+Line™ Proximal Bunion Correction System.
“The Axi+Line™ Proximal Bunion Correction System represents a significant advancement in the treatment of moderate to severe hallux valgus and is complementary to our Re+Line® Bunion Correction System. The Axi+Line™ system leverages the recognized benefits of the Mau osteotomy, while allowing our surgeons to have confidence in their operative technique. As with our other products, the final repair is very stable thanks to the innovative plating system, giving surgeons peace of mind and patients the potential to quickly get back to their daily activities,” said Director of Product Development, Ryan Schlotterback.
Rod K. Mayer, President of Nextremity Solutions said, “We are very excited to receive 510(k) approval from the FDA for this new and innovative treatment option for patients. I’m extremely proud of our team and their efforts to produce yet another state-of-the-art device for the treatment of deformities in the forefoot. We look forward to taking the next steps to release this product into the hands of our surgeon consultants in our upcoming beta launch.”
The Nextremity Solutions Axi+Line™ Proximal Bunion Correction System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot. An application for a CE mark is pending.
About Nextremity Solutions, Inc.
Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company’s procedure-ready, sterile implant systems for the correction of foot and ankle pathologies include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.
For further information, visit www.nextremitysolutions.com or call Dave Temple, Director of Marketing & Corporate Communications at 574-635-3022.