Theracor

Theracor is a wound dressing derived from human umbilical cord extracellular matrix that is lyophilized and packaged in sheet form. It is intended to cover, protect, and provide a moist wound environment for managing acute and chronic wounds including pressure ulcers, diabetic ulcers, surgical wounds, and trauma wounds.

Theracor is identical to its predicate device Corplex P/Theracor P/Allacor P in intended use, indications, materials, components, moisture content, sterilization method, sterility assurance level, and shelf-life. The primary differences are device format (sheet vs. particles) and packaging (dual peel-open pouch vs. glass vial), which are minor and mitigated by performance and safety testing.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-6:2016 (implantation), ISO 10993-10:2010 and 2021 (irritation and sensitization), ISO 10993-11:2017 (systemic toxicity), ISO 10993-17:2002 and ISO 10993-18:2020 (chemical characterization), ISO 21726:2019, and ANSI/AAMI/ST72 (endotoxin testing). Performance testing included extracellular matrix characterization and residual moisture analysis.

Theracor is substantially equivalent because it shares the same intended use, indications, materials (human umbilical cord ECM with collagen and associated components), sterilization method, and shelf-life as the predicate. Minor differences in format and packaging do not raise different safety or effectiveness questions and are supported by comprehensive biocompatibility and performance testing demonstrating equivalent safety and effectiveness.