(12 days)
The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.
The Trochanteric Nail System consists of an intramedullary nail, lag screw, end cap, and optional anti-rotation screw, all manufactured from titanium alloy (Ti-6Al-4V ELI), which are used to treat fractures in the proximal portion of the femur. The lag screw provides dynamic compression of the fracture; the anti-rotation screw can be used to prevent the rotation of the bone fracture segments, and the end cap prevents bone ingrowth. It is estimated that the AR screw is required in only five to ten percent of the cases where additional rotational stability of the fracture is required.
This 510(k) summary (K042325) for the DePuy Orthopaedics Trochanteric Nail System does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. It focuses on device description, intended use, and indications, and then asserts substantial equivalence based on similar use, indications, materials, and sterilization processes to previously cleared DePuy Trochanteric Nail predicate devices (K010780 and K013563).
Therefore, I cannot provide the requested information from this document. To answer your questions, I would need a study report that details performance testing and acceptance criteria for the Trochanteric Nail System.
§ 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.