(22 days)
The Koby Surgical Internal Fixation System implants are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
These implants are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The Koby Surgical Internal Fixation System consists of a series of cannulated and non-cannulated bone screws which vary in diameters and lengths. These screws are constructed from implant-grade titanium and are used to aid in the fixation of bones in the upper and lower extremities.
The provided document is a 510(k) summary for the Koby Surgical Internal Fixation System, which is a regulatory submission to the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Specifically, the document is a premarket notification for a medical device seeking substantial equivalence to existing legally marketed devices. It describes the device, its intended use, materials, and classification. The FDA's letter indicates that based on this information, the device is considered substantially equivalent to a predicate device.
Therefore, I cannot fulfill the request to describe acceptance criteria or a study based on the provided text, as this information is not present in the document.
§ 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.