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LIGAFIX 30 is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (30% β-TCP) and Poly Lactic Acid (70% PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX 30° resorbable cannulated screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX 30® interference screws are made of a ceramic (30% ß-TCP) / polymer (70% Poly Lactic Acid -PLA) composite.

LIGAFIX 30° interference screws are supplied sterile and individually packaged in double heat sealed pouches.

This document is a 510(k) summary for the LIGAFIX® Resorbable Interference Screw. It describes the device and its intended use, and states that substantial equivalence is based on similar fundamental scientific technology, operating principle, and intended use as a previously cleared predicate device (K050407), with modifications limited to additional screw sizes and a slightly modified head design.

Therefore, the submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission for substantial equivalence based on modifications to an already cleared device, not a performance study.

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