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Normed Titanium Rondo Fix Fusion Plate and Screw System intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones, patients suffering pain and/or loss of function due to osteoarthritis, post traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, rheumatoid arthritis and tumor resection. The system can be used in both adult and pediatric patients.

Normed Titanium Rondo Fix Fusion Plate and Screw System consists of a series of convex/concave plates in various shape and length which are attached to the bone using screw fixation. The plates are available in 1.0 mm plate thickness and can be contoured as needed to fit the specific anatomy. The self-tapping 2.3 mm screw diameters will be available in two screw head designs, standard cross-lock and square lock.

This document is a 510(k) summary for a medical device. It does not include information about acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.

The document discusses the device name, intended use, classification, and regulatory status (specifically, substantial equivalence to a predicate device). It's a premarket notification, indicating that the device is being cleared for market based on its similarity to existing cleared devices, rather than through a new clinical trial demonstrating specific performance metrics against pre-defined acceptance criteria.

Thus, all sections of your request remain unanswerable from the provided text, as they pertain to performance testing and evaluation, which is not present in this regulatory submission.

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