Kerecis SurgiBind (50241)

Kerecis SurgiBind (50241) is a lyophilized, terminally sterilized surgical mesh made from biocompatible, resorbable wild North Atlantic cod fish skin. It is intended for single-use implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery.

The subject device is identical to its predicate device (Kerecis Reconstruct, K202430) in materials (Atlantic cod fish skin), design, manufacturing process, sterilization method (ethylene oxide), and intended use. The only difference is that the subject device adds autologous body fluids (such as blood) as optional rehydration fluid options in the Instructions for Use, in addition to the predicate's sterile saline and Ringer's solution.

Not stated in this summary.

Substantial equivalence is supported because the subject device shares identical intended use, functions, mode of action, and fundamental scientific technology as the predicate device. Both are composed of the same materials and manufactured using identical processes. Performance testing leveraged from the predicate device confirmed comparable results; additional rehydration and suture retention tests using autologous body fluid were performed to validate the labeling modification and confirmed device performance remains consistent. Since only the rehydration fluid options in labeling changed—not the fundamental technology or intended use—the device performs comparably to the predicate for the same intended use.