(193 days)
The MAGELLAN™ Intramedullary Femoral Nail System is indicated for use in long bone shaft fractures of the femur which require stabilization of the axis of the bone, including subtrochanteric fractures, intertrochanteric fractures, femoral neck fractures, comminuted fractures, segmental fractures, fractures with bone loss, proximal and distal fractures, nonunions and malunions, and bone lengthening.
The MAGELLAN™ Magnetic Distal Targeting System is designed to locate and lock in place the distal screw holes of the Magellan Intramedullary Femoral Nail without the use of radiographic equipment. The system includes reamers for preparing the intramedullary canal for nail placement; drill bits to drill screw holes proximally, a targeting compass and magnetic target insert to locate the distal screw holes, and targeting Steinmann pins and drill bits (two sizes) to create the distal screw holes. This instrument system is used with power equipment available from other manufacturers, and is certified by the supplier to work with the power source.
The provided text is a 510(k) summary for the MAGELLAN™ Magnetic Distal Targeting System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance testing against specific acceptance criteria.
Therefore, the document explicitly states:
"Because the MAGELLAN™ Magnetic Distal Targeting System is substantially equivalent to the predicate device in design, material, and intended use, testing was not performed."
Given this, I cannot provide the information requested in your numbered points as it is not present in the provided text. The device's clearance was based on its substantial equivalence to pre-amendments predicate devices, not on a study proving it met specific acceptance criteria.
§ 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.