Meniscus Versaflex

Meniscus Versaflex is an all-inside arthroscopic meniscal suture device indicated for repair of the meniscus. It consists of two non-absorbable PEEK implants connected by a UHMWPE suture, pre-assembled in a moldable insertion system offered in curved and reverse-curved configurations, and sterilized by ethylene oxide.

The subject and predicate devices are manufactured from identical materials (PEEK implants, UHMWPE suture) and share equivalent design characteristics, physical dimensions, and technological features. The Versaflex offers a bendable inserter mechanism for improved access to different meniscal regions (posterior, medial, anterior), but these differences are considered minor and do not raise new safety or efficacy issues.

Mechanical testing was performed according to USP standards and procedures from the technical-scientific literature 'Biomechanical Testing of Meniscal Repairs Using the FiberStitch, Smith & Nephew Fast-Fix 360, and Zimmer Biomet JuggerStitch Implants' (Arthrex 2020). Tests included failure load, displacement, suture length, suture diameter, tensile strength (USP), and suture composition.

Meniscus Versaflex is substantially equivalent to the predicate Fast-fix Flex (Smith & Nephew, K203393) because both devices share identical materials, equivalent design and technological characteristics, the same intended use and indications for meniscus repair, equivalent anatomical region and sizes, and mechanically tested strength meeting established acceptance criteria. Minor design differences (bendable inserter) do not raise different questions of safety or effectiveness.