Search Results

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.

Ask a specific question about this device