(14 days)
The Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma, for reconstruction, or arthrodesis. Burr Hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.
The Integra Bone Fixation System includes titanium self-tapping and /or self-drilling screws and plates along with instruments for the internal fixation of bone fragments. The fixation screws are supplied in a variety of diameters and lengths designed to fit Integra's various designs of fixation plates, including mesh plates, and burr hole covers. The Integra Bone Fixation System includes reusable instruments such as screwdrivers, handles and blades, plates holders, benders and cutters, drill bits, and instrument trays. The single use fixation plates and screws, and reusable instruments are provided nonsterile and must be sterilized prior to use.
This 510(k) summary (K050492) for the Integra Bone Fixation System indicates that the device is a modification of a previously cleared device (K040860). Instead of presenting new performance data against acceptance criteria, it asserts substantial equivalence based on the argument that the modifications do not affect intended use, fundamental scientific technology, or raise new safety and effectiveness issues.
Therefore, the provided document does not report on a study that establishes new acceptance criteria or new device performance data for this specific 510(k) submission (K050492). It relies on the previously established substantial equivalence of its predicate device (K040860).
As a result, I cannot provide the detailed information requested in points 1-9 as no new performance study is described in this submission.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.