PowerKnot High Strength Sutures

PowerKnot High Strength Sutures are non-absorbable braided surgical sutures made of 100% ultra-high molecular weight polyethylene (UHMWPE) with a multifilament core and braided sheath. They are indicated for soft tissue approximation and ligation, including use in surgeries with allograft or autograft tissue constructs. The sutures are available in multiple color options with or without a stainless steel needle and include a Running Direction Indicator (RDI) surface feature to aid surgeon visualization.

The subject device has a suture diameter of 0.65–0.68 mm (compared to predicate 0.67 mm), overall length of 990 mm (vs. 965 mm), and needle diameter of 1.28 mm with 26 mm length (vs. predicate 1.32 mm and 26.5 mm). The suture sheath is 100% UHMWPE with no coating, whereas the predicate uses UHMWPE and polyester with silicone elastomer coating. Both use identical braiding patterns (2 over/2 under at ~25° angle) and stainless steel needles. Dyes differ slightly but meet FDA color additive regulations.

Performance testing per USP <871> (Suture/Needle Attachment Strength), USP <881> (Knot-Pull Tensile Strength), ASTM D2256/D2256M–10 (quasi-static and cyclic tensile testing of suture), European Pharmacopoeia §2.6.14 for bacterial endotoxin (LAL test), USP chapter <151> for pyrogen testing, and ASTM F899 for stainless steel needle specification.

The device is substantially equivalent because minor dimensional differences (suture diameter ±0.01 mm, length +25 mm, needle diameter −0.04 mm) and material variations (100% UHMWPE sheath vs. mixed composition, absence of silicone coating) do not negatively impact safety or effectiveness, as validated by mechanical testing that confirms adequate strength and performance. The RDI surface feature is a surgeon aid that introduces no new clinical risks. Different dyes comply with FDA regulations and are already used in reference devices. The braiding design, intended use, biocompatibility category, and single-use format are identical to the predicate, and performance testing demonstrates equivalent mechanical properties.