Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

Arthrex FiberTape, TigerTape, and Radiopaque FiberTape Cerclage Sutures are nonabsorbable braided sutures made from Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester, designed for soft tissue approximation and ligation. They are used as bone fixation cerclage in orthopedic and spinal surgery, including applications such as hip arthroplasty, sternotomy rewiring, trauma surgery fracture repair, and spinal column wiring.

The subject devices have identical intended use, materials, fundamental scientific technology, design, packaging, sterility, shelf-life, and MRI safety labeling compared to the predicate devices. The Radiopaque variant incorporates Bismuth Trioxide (Bi2O3) for radiopacity. The devices include cyanoacrylate at suture ends (removed during procedure) and may contain a FiberLink shuttling suture for passing only.

Dynamic tensile fatigue testing in fluid for 5 million cycles per EP 2.6.14/USP <85> for bacterial endotoxin testing to demonstrate pyrogen limit specifications compliance.

The devices are substantially equivalent because they share the same intended use (soft tissue approximation and bone fixation cerclage), identical materials and fundamental scientific technology, and equivalent design and performance characteristics to the predicate devices. Performance testing demonstrates dynamic tensile fatigue equivalence to the primary predicate (Kinamed SuperCable Iso-Elastic), and the minor differences (addition of radiopacity, expanded indications for spinal and acromioclavicular applications) do not raise new questions about safety or effectiveness since these applications were previously cleared for similar predicate devices.