(90 days)
The Endotack is intended for use to provide tibial fixation for surgical correction of cruciate ligament ruptures as well as for cruciate ligament implant replacement.
The Endotack is a button fixation device. The body contact portions of the Endotack are composed of titanium, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary and FDA clearance letter for a medical device called "Endotack," a suture anchor. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not include details on performance testing, acceptance criteria, or study methodologies.
§ 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.