Syndesmosis TightRope PRO

The Syndesmosis TightRope PRO is a bone fixation device comprised of metal buttons (round and oblong) preloaded onto an inserter with suture and a washer or buttress plate. It is intended as an adjunct in fracture repair for small bone fragments and to provide fixation of syndesmotic disruptions in connection with Weber B and C ankle fractures during the healing process.

Compared to predicate devices, the PRO features a 2-hole oblong button with smaller width, a 4-hole round button that is thinner, a smaller drill bit diameter, a new 1-hole button extending washer, and preassembly with #2-0 FiberWire passing suture. The fundamental design, materials, button configuration, dimensions, MRI safety labeling, sterility, and shelf-life remain the same as predicates.

Cyclic shear testing and ultimate shear testing per acceptance criteria from predicate K043248; MRI safety testing per ASTM F2052, ASTM F2119, ASTM F2182, and ASTM F2213 standards; FDA guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.