Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)

Remplir is a sterile, implantable, resorbable collagen membrane derived from porcine tissue, supplied in four sizes (15×20 mm to 40×50 mm). It is wrapped around peripheral nerve injuries to protect the nerve, guide regenerating axons into the distal stump, and prevent connective tissue ingrowth during healing in cases where there has been no substantial loss of nerve tissue.

Remplir is a single-ply sheet of porcine-derived, non-crosslinked Type I collagen with smooth and rough surfaces, resorbable, suturable, and absorbent while retaining mechanical strength when wet. It differs from the predicate NeuraWrap primarily in composition (porcine vs. bovine collagen) and sterilization method (gamma irradiation vs. ethylene oxide), though both are sterile single-use devices in identical packaging.

ISO 10993 (biocompatibility), ISO 11137 (sterilization and sterility assurance level of 10⁻⁶), USP <85> and AAMI ST72 (endotoxin testing), and USP <161> (endotoxin specification).

Although Remplir uses porcine collagen instead of bovine and gamma irradiation instead of ethylene oxide sterilization, the device demonstrates identical technological characteristics (resorbable, suturable, absorbent, mechanical strength retention) and identical indications for use. Bench testing (suturability and tensile strength) and a rat sciatic nerve transection model showed comparable performance and biocompatibility to the predicate NeuraWrap, with no or minimal tissue reaction at 4, 12, and 24 weeks, establishing functional and clinical equivalence despite material sourcing differences.