(90 days)
The Multithread Vilex Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, and Tendon Attachment. It is intended for, but not limited to Hand Surgery, Orthopedic and Podiatric Surgery, The materials used to manufacture this screw are 316L, implant-quality stainless steel and Ti6Al4V, implant quality titanium alloy.
Not Found
I am sorry, but based on the provided document, I cannot answer the request about the acceptance criteria and the study that proves the device meets them. The document is a clearance letter from the FDA for a medical device (Vilex/Duval/Orthex Cannulated Bone Screw Double Thread) and outlines regulatory information and an "Indications for Use" statement. It does not contain details about specific acceptance criteria, study designs, sample sizes, expert qualifications, or comparative effectiveness 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.