(78 days)
The WishBone K-Wire System, is intended to be used for fixation of pediatric bone fractures, bone reconstruction; and guide pins for insertion of other implants.
Not Found
This document is a 510(k) clearance letter from the FDA for the WishBone K-Wire System. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria or specific study data proving the device met those criteria. The document is a regulatory clearance letter, not a clinical study report or a technical performance specification document.
Therefore, I cannot provide the requested information based on the input text. The questions asked are typically addressed in a clinical or performance study report that would be submitted to the FDA as part of the 510(k) application, but this letter is the FDA's response to that application, not the application itself.
To answer your questions, I would need a different type of document, such as:
- A summary of safety and effectiveness (SSE) for the 510(k).
- A clinical study report.
- A performance testing report.
§ 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.