(193 days)
The Groupe Lepine EIS threaded compression screw system is intended to be used as a fixation screw of the first metatarsal after a corrective osteotomy, or for fixation of small bones after trauma fractures.
The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or trauma fractures.
EIS Threaded Compression Screw System
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the EIS Threaded Screws for Metatarsal Fixation, which describes the device's intended use and market clearance, but does not include any details about acceptance criteria, a study validating the device's performance, or the specific information you've requested regarding AI or clinical studies.
§ 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.