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Intended Use:
Fixation of bone fragments

Indications For Use:

• 1. Bone fractures
• 2. Bone reconstructions
• 3. Bone traction

Not Found

The provided text is a 510(k) Premarket Notification for a medical device called "The Bone Tie." This type of document is for regulatory approval and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) submission process is primarily about demonstrating "substantial equivalence" to a predicate device already on the market, rather than proving the device meets specific performance acceptance criteria through a clinical study. It focuses on the device's design, materials, and intended use being similar to an already approved device.

Therefore, I cannot provide the requested information based on the input text. The document describes:

1. Device Name: THE BONE TIE
2. Intended Use/Indications For Use: Fixation of bone fragments for bone fractures, bone reconstructions, and bone traction.
3. Classification: Class II, Product Code HTY, as a "Smooth or threaded metallic bone fixation fastener."
4. Regulatory Approval: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

To answer your request, I would need a different type of document, such as a clinical study report or a detailed design verification and validation document, which would explicitly describe acceptance criteria and present study results against those criteria.

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