(76 days)
The STERLING® Interference Screw ST is used to provide interference The STERENTO - and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft; fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.
The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 15 to 40mm and diameters ranging from 7 to 10 mm. The STERLING® Interference Screw ST is threaded, has an internal hex-drive, and has a rounded proximal head.
This document does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) premarket notification for the "STERLING® Interference Screw ST" and the FDA's response letter.
The primary purpose of this document is to demonstrate "substantial equivalence" to predicate devices, not to present performance data against specific acceptance criteria.
Therefore, I cannot provide the requested table and study information based on the provided text.
§ 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.