OviTex PRS (Long-Term Resorbable)

OviTex PRS (Long-Term Resorbable) is a sterile surgical mesh composed of ovine extracellular matrix reinforced with poly(lactic co-glycolic acid) polymer. It is implanted to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery, supplied sterile for one-time use.

The subject device has identical technological characteristics to the predicate device, including the same materials of construction (ovine ECM and PLGA polymer) and principle of operation. Two modifications were made: removal of a foil packaging layer (sterile barrier unchanged) and introduction of two new device configurations (25 cm diameter circle and 25×30 cm oval), both with three layers of decellularized extracellular matrix embroidered with PLGA suture.

Real-time shelf life testing confirmed specification compliance through 18 months of storage. Non-clinical testing included endotoxin and ethylene oxide sterilization residuals quantification per ISO 10993-7:2008.

The subject device demonstrates substantial equivalence because it retains the same indications for use, materials, and principle of operation as the predicate device K214070. The packaging change does not affect the sterile barrier or device function. The new device configurations maintain the same three-layer decellularized ECM structure and PLGA suture construction as existing offerings, and non-clinical testing confirmed they met predefined acceptance criteria for biocompatibility and sterilization residuals.