Helios Dura Regeneration Matrix

The Helios Dura Regeneration Matrix is a sterile, single-use collagen implant derived from fetal bovine dermis, supplied in sheet form (6.5–250 cm²), designed to be trimmed, sutured, or onlaid by surgeons to repair defects in the dura mater—the membrane surrounding the brain and spinal cord.

The device is an acellular dermal matrix collagen implant in single-ply solid sheet form (square or rectangle), sterilized by ethylene oxide (SAL 10⁻⁶), stored dry at room temperature (15–30°C), with a 3-year shelf life from lyophilization. It lacks chemical crosslinking and is identical to the predicate device in material composition, fundamental technology, form, design, sterilization method, storage, and shelf life; size ranges are substantially equivalent.

Not stated in this summary.

Helios Dura Regeneration Matrix is substantially equivalent to Durepair® Dura Regeneration Matrix (K161370) because both devices share identical indications for use, materials (collagen, extracellular matrix from fetal bovine dermis), fundamental technology (acellular dermal matrix implant), form, design, sterilization, storage, and shelf life. Performance data from identical reference devices (CardiaMend™ and SurgiMend™) covering device characterization, design validations (viral inactivation, sterilization), biocompatibility, shelf-life, and packaging testing support the equivalence, demonstrating the devices perform substantially the same function with the same intended use.