(70 days)
The Futura Biomedical Tapered Compression Pin is intended to be implanted for the fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis of the foot and ankle and hand and wrist.
The Futura Biomedical Implant is a one-piece device made of Stainless Steel or Titanium Alloy, intended for fixation of bone fractures, bone reconstruction, osteotomy or Andy, intended 101 - 121 is designed in 3 sizes. The device is tapered and threaded on the leading end and smooth on the trailing end. The implant is used in the treatment or the feactures of bone reconstruction, including osteotomy, and joint fusion. The design of the Futura Biomedical Tapered Pin is similar in shape and size to the Newdeal TAC of the Patare Dietices consist of a tapered, threaded pin that fits into a pin driver. Surgical instruments include a k-wire, drill, pin cutter, pliers, and trephine. No new materials are used in the development of this implant.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.
The document is a 510(k) summary for a medical device called the "Tapered Compression Pin" and its associated FDA clearance letter. It details the device's description, indications for use, comparison to a predicate device (Newdeal TAC pin), and the FDA's decision of substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study as requested, as this information is not present in the given text.
§ 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.