(83 days)
The BTI™ brand Large (7.0 mm) Cannulated Transfixing Screw is indicated for single use with the BTI brand Proximal Humeral Intramedullary Rod, the BTI brand Mid-Shaft Humeral Intramedullary Rod and the BTI brand Tod, the Britishedullary Rod Systems to stablifize fractures.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "BTI Large (7.0 mm) Transfixing Screw." It does not describe the acceptance criteria or a study that proves the device meets those criteria. Instead, it indicates that the FDA has determined the device to be "substantially equivalent" to legally marketed predicate devices.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance and provides instructions on labeling and permissible uses of the device, particularly regarding its non-use for pedicular screw fixation.
§ 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.