Restrata Soft Tissue Reinforcement (STR)

Restrata Soft Tissue Reinforcement (STR) is an electrospun fiber matrix composed of resorbable synthetic polymers (polyglactin 910 and polydioxanone) intended for surgical implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is sterile, single-use, and available in multiple sizes.

The subject device is composed of synthetic resorbable polymers (PGLA 90:10 and PDO fibers), whereas the predicate device (Kerecis Reconstruct) is derived from cod fish skin. Both devices are sterilized via E-beam to a sterility assurance level of 10^-6, though the predicate uses ethylene oxide sterilization. The subject device has a 2-year shelf life compared to the predicate's 3 years, and offers comparable size options.

Not stated in this summary.

Although the subject and predicate devices differ materially—synthetic polymers versus fish skin—substantial equivalence is supported by benchtop performance testing demonstrating equivalent mechanical properties (flexural stiffness, tensile strength, suture pullout, burst, and tear resistance) and a comparative animal study confirming comparable safety and effectiveness. Both devices share identical intended use, classification, and regulatory designation, and the subject device leveraged biocompatibility data from previously cleared versions with the same material composition, establishing that the performance differences do not raise safety or effectiveness concerns.