(65 days)
The Endoflip graft fixation device is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries.
Endoflip graft fixation device for femoral fixation of hamstrings grafts in cruciate ligament reconstruction.
I am sorry, but the provided text is a heavily redacted FDA document that does not contain information regarding acceptance criteria, study details, or performance data for the "Endoflip" device. The document is primarily a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to a predicate device and outlining regulatory responsibilities.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 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.