(88 days)
The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30mm to 70mm in 5mm increments with a diameter of 4.0 and 7.0 mm. The device is classified as smooth or threaded metallic bone fixation fasteners as Class II devices pursuant to 21 C.F.R. § 888,3040. The fusion rods are implanted using the same instrumentation previously described in K080398, K092375 and K110838.
The provided text states: "No performance testing was required to support the modified labeling that is the subject of the 510(k)."
Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment is available in the provided document. The submission is based on substantial equivalence to a predicate device.
§ 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.