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The Zimmer Distal Radius Plating System is intended for use in surgical reduction, internal fixation, and stabilization of fractures and osteotomies of the distal radius. Examples of distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures, fractures in osteopenic bone, non-unions, and mal-unions.

The Zimmer Distal Radius Plating System is a plate and screw system intended for internal fixation and stabilization of fractures and osteotomies of the distal radius. The Zimmer Distal Radius Plating System consists of Volar, Medial and Dorsal locking plates. All the plates have screw holes which can accept either locking or non-locking screws and slots which can accept only non-locking screws. Locking screws and pegs may be inserted at 15° in any direction (30° cone) from the nominal screw hole trajectory. Thus, anatomically contoured plate design combined with locking screw technology creates fixed or variable angled constructs for use in simple or multi-fragment fractures. All the plates and screws are made from Ti-6AI-4V ELI alloy. All the plates and screws are Type II anodized except the nonlocking screws which are color anodized.

The provided text K133246 is a 510(k) Summary for the Zimmer Distal Radius Plating System. This document describes a medical device and its predicate devices, but does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it describe a study involving an algorithm or artificial intelligence (AI).

The document explicitly states: "Clinical data and conclusions were not needed to show substantial equivalence." This means that the device was approved based on non-clinical performance and similarity to existing predicate devices, rather than a clinical study evaluating its effectiveness against specific performance criteria.

Therefore, I cannot provide the requested information from the given text as it is not present in the document.

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