(199 days)
The MAGELLAN™ Intramedullary Tibial Nail System is indicated for use in long bone shaft fractures of the tibia which require stabilization of the axis of the bone. These include shaft fractures, segmented fractures, fractures with bone loss, comminuted fractures, proximal and distal fractures, nonunions and malunions.
Magellan Tibial Intramedullary Nail
This document is a 510(k) clearance letter from the FDA for the Magellan Tibial Intramedullary Nail. It is not a study report or clinical trial documentation, and therefore, it does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it include information about AI/algorithm performance.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This determination is generally based on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness.
To fulfill your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSE) or the actual clinical study report submitted with the 510(k). This FDA letter only announces the clearance based on that submission.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.