IntraFuse Receives FDA Clearance for FlexThread Fibula Pin

By Julie A. Vetalice

IntraFuse, a startup incubated by Surgical Frontiers, received FDA 510(k) clearance to market the FlexThread™ Fibula Pin system.

This represents the second product in the FlexThread line, and is intended for percutaneous fixation of distal fibula fractures. (The company's first FDA-cleared product was a clavicle pin.)

The distal end of the fibula pin implant is a flexible, intramedullary screw; the proximal end is a rigid, high-strength intramedullary rod. Upon insertion, the rigid rod spans and supports the fracture while the flexible screw portion bends as needed to thread into the intramedullary canal, supporting proper bone alignment. The pin is compatible with either screw or flexible fixation of the syndesmosis joint, as needed.

Source: Surgical Frontiers

Product Labels: Lower Extremity

Tags: 510(k) Clearance, Regulatory