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The Tornier Cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during joint arthroplasty. The Tornier Cement restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation when the implant is introduced.

The Tornier Cement Restrictor is a diaphyseal plug for orthopedic use. It is designed to occlude the medullary cavity before the introduction of acrylic cement. The Tornier Cement Restrictor is used to prevent the cement progression in the diaphysis and therefore facilitate the cement pressurization during the introduction of the implant. Its flexible mechanism makes it adaptable to different diameters of medullary canal to be occluded. The present device modification submission consists in the addition of a small diaphyseal plug and an extension of the indication for use.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for the Tornier Cement Restrictor and primarily discusses its description, materials, indications for use, and its substantial equivalence to predicate devices. It does not include details on clinical studies, performance metrics, ground truth establishment, or expert reviews as requested in your prompt.

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