Nextremity Gets U.S. and EU Okay for New Forefoot Surgery System

Warsaw, Ind.-based Nextremity Solutions Inc. has received 510(k) clearance from the U.S Food and Drug Administration as well as the European CE mark for its latest proprietary forefoot surgery system, the MSP metatarsal shortening plate and system. The MSP system is positioned for metatarsal shortening osteotomies to correct toe angulation/dislocation and relieve pressure. It provides the company with a product candidate in another key segment of forefoot surgery. The company will prepare for a limited product release in the coming weeks.

“The MSP plate is designed to provide a greater level of precision and repeatability because the osteotomy guide and metatarsal reduction/control have been engineered into the implant,” said Lon S. Weiner, M.D., chief of orthopedic trauma at Lenox Hill Hospital in New York City, N.Y. “We enthusiastically await the clinical experience of our surgeon colleagues.”

“Based on my cadaver lab experience with MSP, I believe that the plate’s control of metatarsal segments will provide for a more stable and precise fixation,” commented Judith F. Baumhauer, M.D., MPH, professor, department of orthopedic surgery, Foot and Ankle Division, University of Rochester in New York. “It has the makings of a game changer product.”

Nextremity’s President and CEO Rod K. Mayer said that he was pleased to earn key regulatory approvals for MSP so soon after receiving the go-ahead for its Re+Line bunion correction system in May. “Initial surgeon feedback on MSP is that we have achieved an important innovation for forefoot surgery,” he said. “This is encouraging as we expand our product portfolio.”

Nextremity makes procedure ready, sterile implant systems for the correction of forefoot pathologies.