Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 3ea K-wires with sharps protection, and 1ea Drill Bit with integral handle for manual use.
A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.
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