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Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Subtalar Joint Fusion System

InCore line of products expands with latest addition.


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., announced it has received 510(k) clearance by the Food & Drug Administration to market its upcoming InCore® Subtalar System.

“The subtalar joint can be a difficult joint to prep and fixate. Therefore, expanding the intraosseous InCore prep and fixation system to the subtalar joint was a great logical next step. The InCore Subtalar System’s ability to provide distraction for joint preparation and compression for solid fixation makes it extremely versatile for surgeons,” said Adam Finley, Director of Product Development for Nextremity Solutions.

Expanding on the InCore brand, preceded by the InCore Lapidus System and InCore TMT System, the InCore Subtalar System provides surgeons with a three-part intraosseous fixation option for subtalar joint arthrodesis. Subtalar arthrodesis is the surgical fusion of bones that form the subtalar joint. This complex joint is located below the ankle joint and is formed by the union of the calcaneus (heel) and the ankle (talus) bones. The subtalar joint transfers load from the foot to tibia or from the tibia to foot and allows side-to-side movement of the foot. Deformities or instability can occur in this joint, as well as arthritis, resulting in pain to patients.

Ryan Schlotterback, Chief Technology Officer for Nextremity Solutions commented, “The InCore Lapidus and InCore TMT systems have been well received and we look forward to launching our newest InCore Subtalar system. I’m proud of our team and happy how they’ve driven this project ahead of schedule. We received this 510(k) clearance right before the end of the year to cap off a very busy 2021. We are looking forward to an exciting 2022 with a number of new system launches.”

“This is the fourth 510(k) clearance that was achieved in 2021 by Nextremity Solutions and is evidence of our culture of innovation and teamwork. As these technologies enter the marketplace in 2022, it once again proves out our i3 Strategic Solutions product development and commercialization strategy. I couldn’t be more proud of this team of talented and driven individuals,” added President & CEO, Rod K. Mayer.

The Nextremity Solutions InCore Subtalar System is indicated for reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the foot. The three-part construct is specifically intended for internal fixation for Subtalar Joint Arthodesis (also known as Subtalar Joint Fusion).

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.

Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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