(70 days)
The 9 x 25mm S.I.S. ACL Fixation Screw for Tibial Fixation of Hamstring Tendons Grafts
The 9 x 25mm S.I.S. ACL Fixation Screw is substantially equivalent to the Arthrex Inc. Cannulated Sheathed Interference Screw, the Concept, Inc. Cannulated Conical Tip Interference Screw, the Depuy Kurosaka Fixation Screw, and the Smith & Nephew RCI ACL Fixation Screw with regard to basic design, intended use, material, and size. The screws are made from implant grade titanium (T16A14V ASTM F136) which is a well know and accepted material for implantable devices. The 9 x 25mm S:I.S. ACL Fixation Screw for Tibial Fixation of Hamstring Tendons Grafts functions the same as the Smith & Nephew RCI ACL Fixation screw for Hamstring Tendons Graft Fixation in the Tibial Tunnel.
The provided text is a summary of safety and effectiveness for a medical device, specifically the Smith & Nephew 9 x 25mm S.I.S. ACL Fixation Screw. This document is a 510(k) summary, which is typically submitted to the FDA to demonstrate that a new device is substantially equivalent to a predicate device already on the market.
Crucially, this document does not contain information about acceptance criteria or a study demonstrating the device meets those criteria (in the sense of a performance study with metrics like sensitivity, specificity, etc.).
Instead, it focuses on demonstrating substantial equivalence based on:
- Design: Similar to predicate devices.
- Intended Use: Similar to predicate devices.
- Material: Implant grade titanium (T16A14V ASTM F136), a well-known and accepted material.
- Size: Similar to predicate devices.
- Function: Functions the same as a previously cleared Smith & Nephew RCI ACL Fixation screw for Hamstring Tendons Graft Fixation in the Tibial Tunnel.
Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document is about regulatory clearance based on equivalence, not a performance study against specific acceptance criteria.
§ 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.