Rotium

Rotium® is a surgical mesh composed of two biodegradable polymer fibers (PLCL and PGA) designed to protect and manage tendon injuries where there has been no substantial loss of tendon tissue. It functions as a non-constricting protective layer between the tendon and surrounding tissues, is conformable for easy placement, and comes in sterile single-use sizes ranging from 20mm × 20mm to 70mm × 25mm.

Rotium® has very similar technological characteristics to the predicate TAPESTRY Biointegrative Implant, including comparable physical and mechanical properties such as materials, construction, size, thickness, and suture retention strength. Both devices are composed of bioresorbable polymer fibers and function as protective layers for tendon injuries.

ISO 10993 Biological Evaluation of Medical Devices, with specific testing including cytotoxicity, intracutaneous reactivity, sensitization, acute and 20-week systemic toxicity, implantation studies (4, 8, and 20 weeks), genotoxicity, and pyrogenicity testing.

Rotium® is substantially equivalent to TAPESTRY because it shares the same intended use (tendon injury management and protection), indications for use, technological characteristics, and principles of operation as the predicate device with no new novel features. Bench testing demonstrated equivalent dimensional, mechanical, and performance properties, and animal testing in a rabbit calcaneal tendon injury model confirmed no new safety or effectiveness issues were introduced.