Universal Tendon Spacer

The Universal Tendon Spacer is a silicone medical device for temporary implantation (2-6 months) used in two-stage hand tendon reconstruction surgery. It creates a neo-sheath around flexor and extensor tendons to allow them to slide and function again after trauma, failed repair, or rupture. The device is a single-size ovoid rod with gradually widening diameter, intended for single use in adults and children.

The device uses medical-grade silicone elastomer with barium sulfate for radio-opacity, manufactured via injection molding with gamma irradiation sterilization—identical materials, design, dimensions, and manufacturing process to the predicate Single Size Tendon Spacer. Mechanical testing (tensile strength, elongation, strain at break per NF EN ISO 527-2) demonstrated equivalence to the predicate.

NF EN ISO 527-2 (tensile strength testing); FDA Blue Book Memorandum #G95-1 and ISO 10993-1 (biocompatibility including cytotoxicity, sensitization, irritation, pyrogenicity); ISO 11607-1, ISO 11607-2, and NF EN 868-5 (packaging integrity and shelf-life validation); USP Class VI material compliance.

The subject device is substantially equivalent because it shares identical intended use and indications for use with the predicate, employs the same materials, design geometry, and manufacturing process (same mold, injection molding, sterilization), and demonstrates equivalent mechanical performance through comparative testing. Both function as temporary implants for two-stage hand tendon reconstruction with no new safety or effectiveness concerns raised by the design characteristics.