FDA Grants clearance to MXO's dynaMX Compression Staple featuring Malleable Nitinol Technology

MX Orthopedics, Corp. (MXO), a leader in superelastic technologies for orthopedic implants, announces the recent FDA clearance (K143622) of its patent-pending dynaMX™ Compression Staple featuring Malleable Nitinol Technology.

MX Orthopedics, Corp. (www.mxortho.com) is a privately-held medical device company focused on the design, development, and commercialization of dynamic orthopedic implants manufactured from superelastic Nitinol. MXO's mission is to create novel implants that are engineered to improve patient outcomes, are easy for surgeons to use, and are cost effective. MXO's recently FDA cleared dynaMX™ Compression Staple is the first staple to combine superelastic legs for compression with a malleable bridge that can be contoured by the surgeon to match the patient's anatomy for improved functionality and comfort. "MXO utilized its vast Nitinol processing expertise to create the dynaMX™ Compression Staple," says Matthew Fonte, CEO of MXO.

The dynaMX™ Compression Staple is initially indicated for fracture and osteotomy fixation of the hand and foot, joint arthrodesis of the hand and foot, and fixation of proximal tibial metaphysis osteotomy. The dynaMX™ Compression Staple is part of MXO's broader fracture fixation portfolio. "The dynaMX™ product line represents the next generation of fracture fixation and utilizes MXO's metallurgical and engineering expertise, resulting in simple and intuitive implants that benefit patients," says Fonte. The dynaMX™ portfolio of superelastic products includes compression staples, screws, plates, and intramedullary implants for various indications in the large and growing orthopedic markets: extremities; trauma; large joints; spine; and thoracic. dynaMX™ implants do not require temperature activation and utilize simple single-use instrumentation. MXO's products are engineered to reduce the fracture and to generate and maintain compression at the fracture site while healing occurs. MXO is located in the Cambridge Innovation Center (CIC) in Kendall Square, Cambridge, MA.