FDA Clears Nextremity Solutions Foot Fusion System

The FDA has cleared Nextremity Solutions, Inc.’s InCore Lapidus System to fuse the first tarsometatarsal (TMT) joint. It took the agency about three months to decide that the system was substantially equivalent to a previously approved device.

The company called the system a “precision-guided, stable, intra-osseous solution for fusion of the first TMT joint.” The fusion procedure is intended to eliminate joint movement and correct deformity around the first metatarsal.

The first TMT joint, according to AOFAS (American Orthopaedic Foot & Ankle Society), “is an important joint at the inner part of the middle of the foot. The two bones that meet to form this joint are the first metatarsal and medial cuneiform bones. When this joint has too much looseness or movement, the condition is known as hypermobility or instability. When this joint becomes hypermobile, the first metatarsal moves too much in one direction and the first toe compensates by moving too much in the other direction. When this happens, a bunion develops.”

In a May 4, 2018 press release, the company stated the fusion system aides the surgeon in “correction and stabilization of the multi-planar deformity while providing distraction and visibility to allow for the surgeons preferred joint preparation.” The company added that their team also focused on repeatable, procedural efficiency and controlled compression of the final construct.

The system is indicated as a three-part construct intended for internal fixation for first metatarsocuneiform arthrodesis (also known as lapidus or first tarsometatarsal fusion). An application for a CE mark is pending.