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The GRAVITY™ Syndesmosis LP System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C.

The subject GRAVITY™ Syndesmosis LP is a sterile, single-use, device intended to stabilize syndesmotic trauma of the ankle. The subject system consists of UHMWPE suture tensioned between two titanium alloy buttons.

This document is a 510(k) summary for a medical device called GRAVITY™ Syndesmosis LP. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria, a study proving the device meets acceptance criteria, or any performance metrics, sample sizes, or expert involvement as requested.

Therefore, I cannot provide the requested information based on the provided text. The document states that "Performance testing and analysis demonstrated substantial equivalence in side by side construct static and dynamic tensile testing" and "Bacterial endotoxin levels on the final finished form of the device were evaluated using LAL pyrogen testing," but it does not provide any details on the acceptance criteria or results of these tests. It also explicitly states "N/A" for clinical evidence.

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