HyperSuture White/Green Extension Line

The HyperSuture™ White/Green Extension Line is a non-absorbable surgical suture composed of ultra-high molecular weight polyethylene (UHMWPE) braided into cables or tapes. It is intended for general soft tissue approximation and ligation, including use in cardiovascular surgery and allograft fixation in orthopedic procedures. The product is available in multiple sizes (USP #2-0, #2, #5) and lengths (36 or 40 inches), with or without pre-attached stainless steel needles.

The device differs from its predicate only in color additives and tracer material: it uses white UHMWPE with 6-0 green polyester tracer (containing D&C Green No.6 less than 0.75% by weight) instead of black nylon-6,6 tracers. Electrical conductivity testing confirmed the green formulation remains below 2 S/m. All other characteristics—UHMWPE material composition, 302 AISI stainless steel needles, dimensions, sterilization, manufacturing location and process, mechanical strengths, shelf-life, and packaging—remain identical to the predicate.

United States Pharmacopeia (USP) performance requirements for diameter, length, needle attachment, and tensile strength. ISO 10993-1:2018 for biological evaluation of medical devices. Electrical conductivity testing per unspecified standard. 21 CFR 74.3206 for color additive compliance.

The HyperSuture™ White/Green Extension Line is substantially equivalent because it is manufactured using identical processes and materials at the same facility as the predicate device K230311, has identical intended use and indications, and maintains identical mechanical performance (tensile strength, needle attachment) per USP 43. The only modifications are cosmetic (green tracer color instead of black) and the green colorant (D&C Green No.6) has been validated to preserve electrical conductivity below 2 S/m with no adverse biocompatibility implications. All testing demonstrates performance equivalence to the predicate.