Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Metatarsophalangeal Joint (MPJ) Arthrodesis 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., today announced it has received 510(k) clearance by the Food & Drug Administration to market its upcoming InCore® MPJ System.

“The InCore platform continues to demonstrate its utility in foot and ankle applications. The InCore MPJ instrumentation provides built-in compression and positional stability to the fixation site prior to implant placement. Coupled with solid intraosseous implant fixation aimed to minimize hardware prominence, the InCore MPJ System presents a compelling solution for first MPJ fusion,” said Greg Denham, Director of Product Development, Early Intervention for Nextremity Solutions.

The InCore MPJ System joins the ever-expanding family of InCore products including the InCore Lapidus System for first TMT fusion and the InCore TMT System that is focused on second and third TMT fusion, which received 510(k) clearance earlier this year. The InCore MPJ system corrects deformity in the first metatarsophalangeal joint (MPJ). Pain in the first MPJ typically results from changes in tissue due to atypical foot biomechanics. Individuals usually suffer from this joint pain while walking and experience tenderness in the affected foot.

Ryan Schlotterback, Chief Technology Officer for Nextremity Solutions said, “We’re continuing to build momentum around our InCore technology platform. With elective surgeries opening back up and picking up steam, we are excited to introduce InCore TMT and InCore MPJ to the market. It is going to be a busy year for Nextremity Solutions and our surgeon teams with several additional 510(k) and product launches on deck. I’m proud of the team and the vigorous execution of our strategy – regardless of the external environment.”

President & CEO, Rod K. Mayer added, “I am very proud and thankful for the continued advancements our Nextremity Solutions team members deliver to the marketplace. We remain dedicated to solving unmet patient needs, providing repeatable outcomes for surgeons, and increasing shareholder value as we continue to develop new products.”

The Nextremity Solutions InCore MPJ System is a three-part construct intended for internal fixation for First Metatarsophalangeal Joint Arthrodesis (also known as 1st MPJ Fusion).

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held strategic commercialization organization with a focus on the extremity musculoskeletal space, offering innovative solutions and Revenue Ready products for various extremity 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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