(27 days)
The ULTiMAX™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malleolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTI ULTiMAX™ Humeral Intramedullary Rod System.
Not Found
This document is a 510(k) clearance letter from the FDA for the ULTIMAX™ Cortical Bone Screws. It states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria. Such information would typically be found in the 510(k) submission itself, not the clearance letter.
To fully answer your request, I would need access to the actual 510(k) submission for K990513, which is not provided in your input.
Based on the provided text, I can only state that the document does not contain the information requested in your bulleted list.
§ 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.