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The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures:

• · Fracture fixation, including single, segmental, and comminuted fractures
• · Revision, including nonunion and malunion
• · Intra- and extra-articular fractures
• · Compression fracture
• · Displaced fracture
• · Reconstruction
• · Replantation
• · Arthrodesis
• · Osteotomy

VariAx 2 is a system used for internal fixation applications and is composed of sterile and nonsterile screws, washers, and instruments. In addition to independent use, screws of this system are also used with compatible, internal fixation systems. These devices are made of titanium alloy, with Type III anodization, and are available in a variety of sizes and diameters, as well as locking and non-locking types.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, as well as no mention of sample sizes, data provenance, expert panels, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

The document is a 510(k) premarket notification summary for the VariAx 2 System, which is a medical device for internal fixation. It discusses the device's substantial equivalence to predicate devices based on non-clinical mechanical testing.

Therefore, I cannot provide the requested information.

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