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The Biomet Microfixation Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.

The Biomet Microfixation Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).

The provided document is a 510(k) summary for the Biomet Microfixation Thoracic Fixation System, which is a medical device for stabilizing chest wall fractures. It explicitly states that no non-clinical or clinical performance data was necessary for the determination of substantial equivalence. Therefore, the document does not contain information regarding acceptance criteria or a study proving the device meets those criteria.

The submission relies on claims of substantial equivalence to predicate devices (K121302, Biomet Microfixation Sternal Closure System and K133616, Synthes MatrixRIB Plating System) based on similarities in intended use, materials, and design principles.

As such, I cannot provide the requested information from this document.

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