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Synthes 3.5mm Titanium LCPTM Proximal Tibia Plate is intended treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

The Synthes 3.5mm Titanium LCPTM Proximal Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. The plates are designed for either the right or left tibia and are available in a variety of lengths. The plates are available in a variety of lengths.

The proximal portion of the plate head accepts 3.5mm titanium locking screws, the distal portion of the plate accepts 3.5 mm titanium locking screws, 3.5 mm titanium cortex screws, or 4.0 mm titanium cancellous bone screws.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. It is a 510(k) summary for the Synthes 3.5mm Titanium LCP™ Proximal Tibia Plate, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from a clinical or technical study against predefined acceptance criteria.

Therefore, I am unable to provide the requested information in the specified format from the given text.

The document primarily covers:

• Sponsor and contact information
• Device name and classification
• Predicate device
• Device description
• Indications for Use
• Material

It also includes the FDA's letter confirming substantial equivalence to the predicate, which is a regulatory finding that allows the device to be marketed, but does not detail specific performance-based acceptance criteria or a study proving those criteria were met.

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