HyperSuture All Green Extension Line

The HyperSuture All Green Extension Line is a nonabsorbable surgical suture made from braided ultrahigh molecular weight polyethylene (UHMWPE) strands. It is indicated for general soft tissue approximation and ligation, including use in cardiovascular surgery and allograft tissue fixation in orthopedic procedures. The device is available in cables, loops, and tapes in various lengths and sizes, with or without pre-attached needles.

The candidate device uses green-dyed UHMWPE (with less than 0.75% D&C Green No. 6 by weight) instead of the predicate's white UHMWPE with black nylon tracers. It adds new looped product configurations and additional USP sizes (#0, #1, #3, 1mm, 1.2mm, 1.8mm). Both are composed of the same UHMWPE material with 302 AISI stainless steel needles, manufactured and sterilized using identical processes, with unchanged mechanical properties, shelf-life, packaging, and labeling.

United States Pharmacopeia (USP) 43 performance requirements for diameter, length, needle attachment, and tensile strength. ISO 10993-1:2018 for biological evaluation of medical devices, including biocompatibility testing, implantation studies, chemical characterization, and toxicology assessments.

The devices are substantially equivalent because they share identical intended uses, principles of operation, and core technical characteristics with the predicate devices (K230311 and K242201). The minor differences—green dye additive instead of white coloring with tracers, additional looped products, and new sizes—do not affect safety or effectiveness. Biocompatibility and performance testing confirm no residual risk from these changes, and all mechanical properties and manufacturing processes remain unchanged.