Stitch Cerclage – Suture Tapes

The Stitch Cerclage - Suture Tapes is a bone fixation device made of ultra-high molecular weight polyethylene (UHMWPE) with stainless steel needles, used in orthopedic surgery for internal fixation of bone. It is indicated for sternotomy procedures, including rewiring of osteomized sternums, and repair of long bone fractures from trauma or reconstruction.

The device is manufactured from identical materials to the predicate device (UHMWPE sutures/tapes with AISI300 stainless steel needles per ASTM F899 standard) and shares equivalent design characteristics and physical dimensions. It is provided sterile via ethylene oxide sterilization and assembled on an ABS loader with equivalent anatomical applications.

Testing was based on the article 'Cerclage Performance Analysis – a Biomechanical Comparison of Different Techniques and Materials' (Hägerich et al., 2022) and included chemical composition analysis, creep testing, tension static testing, and fatigue testing. No specific ISO or ASTM standards for cerclage device testing were identified; the submission notes no international standard exists for this device type.

The device is substantially equivalent because it has identical material composition, equivalent design and physical dimensions, the same indications for use, and operates on the same design principles as the predicate device (Arthrex FiberTape and TigerTape). Mechanical performance was demonstrated through testing based on established literature methodology, and any minor differences do not raise new safety or efficacy concerns.