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Synthes Medial Distal Tibia Plates are indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

Synthes Medial Distal Tibia Plates are available in two sizes: 3.5 mm and 4.5 mm. They are pre-contoured to fit the distal tibia anatomy. The plates feature a limited contact - dynamic compression plate (LC-DCP) design and are available in right and left versions. The end of the plate includes a hole for a suture, if necessary. The plates accept 3.5 mm, 4.0 mm, 4.5 mm cortex screws, and 4.0 mm cancellous screws.

The provided text is a 510(k) summary for the Synthes Medial Distal Tibia Plates, which is a medical device. This document does not describe the acceptance criteria or a study proving the device meets those criteria.

Instead, this document focuses on:

• Device identification: Name, common name, classification, and predicate device.
• Device description: Physical characteristics and materials.
• Intended use/indications for use: What the device is designed to treat.
• Regulatory approval: Confirmation from the FDA that the device is substantially equivalent to a legally marketed predicate device.

To answer your specific questions about acceptance criteria and study details, a different type of document, such as a clinical study report, validation report, or specific performance testing report, would be needed. The 510(k) summary is primarily for regulatory clearance based on substantial equivalence, not detailed performance metrics and acceptance criteria from a specific study.

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