Nextremity Solutions Gains FDA Clearance for Metatarsophalangeal Joint Arthrodesis System

By Julie A. Vetalice

Nextremity Solutions Gains FDA Clearance for Metatarsophalangeal Joint Arthrodesis System

Nextremity Solutions received FDA 510(k) clearance to market its InCore® Metatarsophalangeal Joint (MPJ) System, a three-part construct intended for internal fixation for First Metatarsophalangeal Joint Arthrodesis.

InCore MPJ instrumentation provides compression and stability to the fixation site prior to implant placement. The system joins the growing family of InCore products including the InCore Lapidus System for first TMT fusion and the InCore TMT System for second and third TMT fusion, which received 510(k) clearance earlier this year. InCore MPJ corrects deformity in the first metatarsophalangeal joint. Pain in the first MPJ typically results from changes in tissue due to atypical foot biomechanics.

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.”

Product Labels: Lower Extremity

Tags: 510(k) Clearance, Regulatory