(64 days)
The OrthoTec K-Cap System is intended to provide fixation of bone fragments or for bone reconstruction, while providing protection to neighboring tissues.
The OrthoTec K-Cap System includes a K-wire, a protective cap (K-Cap), and applicator/handle for attachment of the cap to the K-wire.
The provided text is a 510(k) Pre-market Notification for the OrthoTec K-Cap System from 1997. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies in the same way a PMA (Pre-Market Approval) might.
Therefore, I cannot provide the requested information from the given input. The document is a regulatory filing, not a detailed technical or clinical study report.
§ 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.