(52 days)
Intended Use:
Fixation of bone fragments
Indications For Use:
-
- Bone fractures
-
- Bone reconstructions
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- 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:
- Device Name: THE BONE TIE
- Intended Use/Indications For Use: Fixation of bone fragments for bone fractures, bone reconstructions, and bone traction.
- Classification: Class II, Product Code HTY, as a "Smooth or threaded metallic bone fixation fastener."
- 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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.