Jewel Soft Tissue Reinforcement Device (102-6005)

The Jewel Soft Tissue Reinforcement Device is a woven tubular polyester mesh implant intended to reinforce soft tissues undergoing reconstruction or repair, particularly extra-articular ligaments such as the medial collateral ligament and lateral collateral ligament. It is designed to allow insertion of an allograft or autograft inside the mesh or to reinforce native tissue, and is gamma sterilized for single use.

Both the subject and predicate devices are biocompatible surgical mesh constructs that share load with primary tissue repair or grafts and provide structural scaffolding during healing. The key technological difference is that the Jewel device is treated with an atmospheric gas plasma process to improve surface wettability of the mesh, whereas the predicate device is not.

Not stated in this summary.

The Jewel device has identical indications for use and principles of operation to the predicate Poly-Tape/Infinity-Lock device—both are implants for soft tissue reinforcement in ligament repair procedures. Performance testing demonstrated that the Jewel device is biocompatible and provides adequate mechanical properties (tensile strength, stiffness, suture retention, etc.) equivalent to the predicate. The atmospheric plasma surface treatment is a minor modification that does not affect safety or efficacy, and the benefit/risk analysis concluded the differences do not alter the device's safety and effectiveness compared to the predicate.