See my interview with Wade Fallin HERE
FDA CLEARS WAY FOR INTRAMEDULLARY FIXATION FOR EXTREMITIES (Orthopedics This Week)
Wade Fallin, the CEO of IntraFuse, says intramedullary fixation is the standard-of-care today for most fractures of the large, long bones of the body due to superior clinical outcomes versus plating systems, yet plating systems are still the standard-of-care for the smaller, long bones of the extremities."
But with the FDA 510(k) clearance of Logan, Utah-based IntraFuse's FlexThread Fibula Pin System, the options for surgeons are widening.
Percutaneous Fixation
The FlexThread provides percutaneous fixation of distal fibula fractures, primarily Danis-Weber B type fractures, or trans-syndesmotic fractures. The company said on November 1, 2017 that the system's "simple and elegant design is easy to insert and cost competitive with today's standard-of-care internal fixation hardware."
The distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod. Upon insertion of the implant into the fibula, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bend...
