Nextremity Solutions received FDA 510(k) clearance to market the InCore® TMT system, a three-part construct intended for internal fixation for Lesser Tarsometatarsal Joint Arthrodesis (also known as Lisfranc Joint Fusion or 2nd/3rd Tarsometatarsal Fusion).
“Preparing the lesser tarsometatarsal joint for fusion and placing fixation poses difficulties due to the challenging bony anatomy and soft tissue. The InCore TMT is an exciting addition to the successful InCore Lapidus system, addressing the need to provide the necessary distraction for visualization and joint preparation, in addition to controlled compression at the fusion site. This new system applies all the advantages of InCore Lapidus including the solid intraosseous fixation construct aimed to minimize hardware prominence. We look forward to seeing this become another important solution to this common but challenging procedure,” said Greg Denham, Director of Product Development, Early Intervention for Nextremity Solutions.
InCore Lapidus for first tarsometatarsal fusion was launched in a single-use sterile version toward the close of 2019.